Zien Medical Technologies LLC
Salt Lake City, UT, US
ZIEN MEDICAL TECHNOLOGIES LLC appears in FDA device records in Salt Lake City, UT. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Zien Medical Technologies LLC between 2022 and 2024. The busiest year on record is 2022, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2024 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009756153 | 3009756153 | ZIEN MEDICAL TECHNOLOGIES LLC | 2490 South 300 West, Salt Lake City, UT 84115 US | 2026 | and 39 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBHAccessories, Arthroscopic
- HRXArthroscope
- QEZAspiration Thrombectomy Catheter
- IKDCable, Electrode
- JOLCatheter And Tip, Suction
- OFCCatheter Introducer Kit
- KRACatheter, Continuous Flush
- MJNCatheter, Intravascular Occluding, Temporary
- DQYCatheter, Percutaneous
- PNOCatheter, Percutaneous, Cutting/Scoring
- MCWCatheter, Peripheral, Atherectomy
- JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- FLLContinuous Measurement Thermometer
- KMKDevice, Intravascular Catheter Securement
- KYGDevice, Irrigation, Ocular Surgery
- GCQEndoscope, Flexible
- FRLFiber, Medical, Absorbent
- HTPFile
- EMIFile, Bone, Surgical
- HTDForceps
- EMHForceps, Rongeur, Surgical
- NABGauze / Sponge,Nonresorbable For External Use
- GDYGauze/Sponge, Internal, X-Ray Detectable
- MDMInstrument, Manual, Surgical, General Use
- HTSKnife, Orthopedic
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- CCWLaryngoscope, Rigid
- GAANeedle, Aspiration And Injection, Disposable
- FMINeedle, Hypodermic, Single Lumen
- PXBPercutaneous Introducer Kit
- ORGPlatelet And Plasma Separator For Bone Graft Handling
- HXBProbe
- HTXRongeur
- HRRScissors, Orthopedic, Surgical
- HWCScrew, Fixation, Bone
- DQDStethoscope, Electronic
- PZGSurgical Eye Tray
- FMFSyringe, Piston
- LLZSystem, Image Processing, Radiological
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- HWTTemplate
- HKYTonometer, Manual
- ITXTransducer, Ultrasonic, Diagnostic
- LRPTray, Surgical
- BYYTube, Aspirating, Flexible, Connecting
- BYXTubing, Pressure And Accessories
- HTNWasher, Bolt Nut
- DQXWire, Guide, Catheter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2800-2015 | PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15 | Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014-July 2015. This led to the decision to recall the product. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain