Varian Medical Systems, Inc.
Palo Alto, CA, US
Varian Medical Systems, Inc. appears in FDA device records in Palo Alto, CA. FDA records list 238 510(k) clearances between and , no PMA records and 6 registered establishments. As of , FDA records show 174 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
9 namesFDA records resolved to Varian Medical Systems, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.recall
- Endocare, Division Of Healthtronicsrecall
- Endocare, Inc.510(k), recall
- HealthTronics, LLCregistration, 510(k), enforcement report, recall
- Varian Brachytherary Virginiarecall
- Varian Medical Systems, Inc. Oncology Systemsenforcement report, recall
- Varian Medical Systems, Oncology Systems510(k), recall
- Varian Medical Systems, Palo Alto, CArecall
- Velocity Medical Solutions, LLC510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 238FDA records hold 238 510(k) clearances for Varian Medical Systems, Inc. between 1996 and 2026. The busiest year on record is 2014, with 15. The most recent is 2026, with 8.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 2 |
| 1997 | 8 |
| 1998 | 4 |
| 1999 | 2 |
| 2000 | 5 |
| 2001 | 7 |
| 2002 | 8 |
| 2003 | 9 |
| 2004 | 5 |
| 2005 | 8 |
| 2006 | 6 |
| 2007 | 12 |
| 2008 | 4 |
| 2009 | 7 |
| 2010 | 7 |
| 2011 | 4 |
| 2012 | 8 |
| 2013 | 7 |
| 2014 | 15 |
| 2015 | 13 |
| 2016 | 7 |
| 2017 | 10 |
| 2018 | 12 |
| 2019 | 5 |
| 2020 | 5 |
| 2021 | 6 |
| 2022 | 7 |
| 2023 | 12 |
| 2024 | 15 |
| 2025 | 10 |
| 2026 | 8 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261856 | Halcyon, Ethos Radiotherapy System (5.0) | IYE | Substantially Equivalent | |
| K261306 | AI Contouring (VA10A) | QKB | Substantially Equivalent | |
| K260750 | Virtual Cone (1.0) | MUJ | Substantially Equivalent | |
| K253026 | Respiratory Gating for Scanners (2.1) | JAK | Substantially Equivalent | |
| K252717 | MAASTRO Rectal Applicator Set | JAQ | Substantially Equivalent | |
| K252815 | ProBeam 360 Proton Therapy System v3.0 | LHN | Substantially Equivalent | |
| K252304 | syngo.via RT Image Suite VC10 | MUJ | Substantially Equivalent | |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0) | IYE | Substantially Equivalent | |
| K252919 | IDENTIFY (5.0) | IYE | Substantially Equivalent | |
| K252884 | Guided Aarhus Applicator Set | JAQ | Substantially Equivalent | |
| K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeam | IYE | Substantially Equivalent | |
| K250099 | Mobius3D (4.1) | IYE | Substantially Equivalent | |
| K250299 | CT/ MR Tandem and Ovoid Set | JAQ | Substantially Equivalent | |
| K250289 | Intracavitary/Interstitial System | JAQ | Substantially Equivalent | |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) | JAQ | Substantially Equivalent | |
| K242957 | Identify (4.0) | IYE | Substantially Equivalent | |
| K242608 | Embozene Color-Advanced Microspheres | KRD | Substantially Equivalent | |
| K241764 | Mould Probe MR Safe | JAQ | Substantially Equivalent | |
| K242463 | ARIA Radiation Therapy Management System (18.1) | MUJ | Substantially Equivalent | |
| K242378 | Eclipse Treatment Planning System (18.1) | MUJ | Substantially Equivalent | |
| K242961 | Intraluminal Applicator Set | JAQ | Substantially Equivalent | |
| K242874 | Gating Reflector Block | JAK | Substantially Equivalent | |
| K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve | JAQ | Substantially Equivalent | |
| K241965 | Catheter Surface Flap Applicator Set (GM11011830) | JAQ | Substantially Equivalent | |
| K241876 | Vitesse (5.0) | MUJ | Substantially Equivalent | |
| K242794 | ONCOZENE Microspheres | KRD | Substantially Equivalent | |
| K241386 | Heyman Packing Applicator Set (GM11004580) | JAQ | Substantially Equivalent | |
| K240480 | IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) | NEY | Substantially Equivalent | |
| K240784 | Temperature Sensor Probe (ABL-18TP20) | NEY | Substantially Equivalent | |
| K240495 | Flexible Fixation Device for Gynecological Applicators (GM11001960) | JAQ | Substantially Equivalent | |
| K232923 | Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) | IYE | Substantially Equivalent | |
| K232623 | Universal Endometrial Applicator Set (GM11009840) | JAQ | Substantially Equivalent | |
| K232949 | Kelowna GYN and Crook Prostate Templates | JAQ | Substantially Equivalent | |
| K232870 | TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) | IYE | Substantially Equivalent | |
| K232113 | Halcyon, Ethos Radiotherapy System | IYE | Substantially Equivalent | |
| K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | LHN | Substantially Equivalent | |
| K231317 | TrueBeam, TrueBeam STx, Edge, VitalBeam | IYE | Substantially Equivalent | |
| K232400 | VariSeed (v10) | MUJ | Substantially Equivalent | |
| K230576 | IDENTIFY | IYE | Substantially Equivalent | |
| K230557 | Eclipse Treatment Planning System (v18.0) | MUJ | Substantially Equivalent | |
| K223839 | TrueBeam, TrueBeam STx, Edge, VitalBeam | IYE | Substantially Equivalent | |
| K230699 | ARIA Radiation Therapy Management (v18.0) | IYE | Substantially Equivalent | |
| K230271 | ISOLIS Cryoprobe | GEH | Substantially Equivalent | |
| K222775 | Aarhus Applicator Set | JAQ | Substantially Equivalent | |
| K222941 | Halcyon, Ethos Radiotherapy System | IYE | Substantially Equivalent | |
| K221791 | ProBeam 360° Proton Therapy System | LHN | Substantially Equivalent | |
| K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device | JAQ | Substantially Equivalent | |
| K221408 | ARIA Radiation Therapy Management (v16.1 MR3) | IYE | Substantially Equivalent | |
| K221448 | ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) | IYE | Substantially Equivalent | |
| K213977 | TrueBeam, TrueBeam STx, Edge, VitalBeam | IYE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005655081 | 3005655081 | HealthTronics, LLC | 1990 Steam Way, Round Rock, TX 78665 US | 2026 | |
| 2916710 | 2916710 | Varian Medical Systems, Inc | 911 Hansen Way, PALO ALTO, CA 94304 US | 2026 | |
| 3008262715 | 3008262715 | Varian Medical Systems, Inc | 9825 Spectrum Drive, Building 2, Austin, TX 78717 US | 2026 | |
| 3007157255 | 3007157255 | Varian Medical Systems, Inc. | 3290 Northside Parkway NW Suite 400, Atlanta, GA 30327 US | 2026 | |
| 3015548663 | 3015548663 | Varian Medical Systems, Inc. | 6212 Hellyer Ave, San Jose, CA 95138 US | 2026 | |
| 3022977243 | 3022977243 | Varian Medical Systems, Inc. | 3550 Lexington Ave N Ste 300, Shoreview, MN 55126 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- NOYAgents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
- NAJAgents, Embolic, For Treatment Of Uterine Fibroids
- KODCatheter, Urological
- FLLContinuous Measurement Thermometer
- LKYDevice, External Penile Rigidity
- KRDDevice, Vascular, For Promoting Embolization
- FASElectrode, Electrosurgical, Active, Urological
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- KNWInstrument, Biopsy
- LHOInstrument, Quality-Assurance, Radiologic
- LNSLithotriptor, Extracorporeal Shock-Wave, Urological
- IXGPhantom, Anthropomorphic, Radiographic
- HRSPlate, Fixation, Bone
- QKBRadiological Image Processing Software For Radiation Therapy
- HWCScrew, Fixation, Bone
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- KXKSource, Brachytherapy, Radionuclide
- OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- NEYSystem, Ablation, Microwave And Accessories
- JAQSystem, Applicator, Radionuclide, Remote-Controlled
- LLZSystem, Image Processing, Radiological
- LNHSystem, Nuclear Magnetic Resonance Imaging
- MUJSystem, Planning, Radiation Therapy Treatment
- LHNSystem, Radiation Therapy, Charged-Particle, Medical
- KPQSystem, Simulation, Radiation Therapy
- KPRSystem, X-Ray, Stationary
- JAKSystem, X-Ray, Tomography, Computed
- GEHUnit, Cryosurgical, Accessories
Recall records
Showing 25 of 174| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1899-2020 | Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation. | After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient carriage primary- secondary interlock due to carriage fault on the MLC that immediately preceded the initiation of the arc treatment. The issue will occur only with MLC software version 8.5 and only affects conformal arc treatments, including VMAT and RapidArc. There have been no reports of adverse health consequences due to this issue. | Class II | Terminated | |
| Z-0771-2019 | Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, elec- tron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. | There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range incorrectly for non-square 3D CT images (either different number of pixels in X and Y, or non-square pixels). Before the dose is calculated, Eclipse resamples the CT images to create a calculation image with a maximum resolution of 256 x 256. The PCS algorithm assumes uniform resolution in X and Y directions, or that X = Y for all images, and erroneously sets the Y = X for dose calcu- lation. For images that are not square, where either X<>Y, or the length of X does not equal the length of Y, the computed water equivalent range R is erroneous compared to the correct range R: 1) X=Y; R =R (R is correct); 2) XY R >R (R is too big). | Class II | Terminated | |
| Z-0005-2019 | VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. | Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system. | Class II | Terminated | |
| Z-0004-2019 | TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. | Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system. | Class II | Terminated | |
| Z-0990-2017 | Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. | Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Treatment Planning System. The issue only occurs if certain conditions are fulfilled. | Class II | Terminated | |
| Z-0077-2017 | Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated. | Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue | Class II | Terminated | |
| Z-2150-2016 | Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery. | Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS]. | Class II | Terminated | |
| Z-2149-2016 | Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery. | Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS]. | Class II | Terminated | |
| Z-0805-2016 | Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. | When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for unintended radiation exposure. | Class II | Terminated | |
| Z-0170-2016 | ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application. | An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx. | Class II | Terminated | |
| Z-1849-2015 | The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy. | After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction generated by the system will not be correct. The application freeze issue affects only the systems equipped with magnetic Hard Disk Drives (HDD). | Class II | Terminated | |
| Z-1829-2015 | Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set. | Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM11010080 2012-09-06. The actual dose rate of the applicator is approximately 14% higher than the rate published within the IFU. Use of the dose rate as provided by the IFU without modification or independent confirmat | Class II | Terminated | |
| Z-2654-2014 | 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan. | Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used with BCCV. | Class II | Terminated | |
| Z-2567-2014 | C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. | Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode. | Class II | Terminated | |
| Z-0526-2015 | Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial land marks. | Varian MedicalSystems' X-ray generator Supplier (CPI) has identified that 32 VMS150 X-ray Generators were shipped that are missing a ground wire between the EMIbraid on the induc tion assembly cable and the ground stud on the lid of the High Voltage Module. | Class II | Terminated | |
| Z-1502-2014 | On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks. | Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning. | Class II | Terminated | |
| Z-0552-2014 | Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation. | An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change. | Class II | Terminated | |
| Z-0439-2014 | C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. | This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation. | Class II | Terminated | |
| Z-0065-2014 | VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA | The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization. | Class II | Terminated | |
| Z-1275-2014 | DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. | An anomaly was detected such that, under certain conditions, a summed dose created by Velocity replaces the calculated dose from an approved plan in Eclipse when importing the dose from Velocity. | Class II | Terminated | |
| Z-1163-2013 | Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion. | Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions. | Class II | Terminated | |
| Z-0867-2013 | Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. | The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used. | Class II | Terminated | |
| Z-0825-2013 | HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for freezing and ablation of tissue. | The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date. | Class II | Terminated | |
| Z-0531-2013 | Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA | Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where a 360 degree arc field may convert to static field during DICOM export or import. | Class II | Terminated | |
| Z-0607-2013 | Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for Brachytherapy. | The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Varian Medical Systems, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain