Avid Medical, Inc. a Medical Action Ind. Company 305
Toano, VA, US
AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305 appears in FDA device records in Toano, VA. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 184 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Avid Medical, Inc. a Medical Action Ind. Company 305 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.
- Avid Medical, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 2 510(k) clearances for Avid Medical, Inc. a Medical Action Ind. Company 305 in 2000.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1047429 | 1047429 | AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305 | 9000 WESTMONT DR., TOANO, VA 23168 US | 2026 | and 72 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAZAnesthesia Conduction Kit
- OFQAnesthesia Kit
- OEQAngiography/Angioplasty Kit
- KXGApplicator, Absorbent Tipped, Sterile
- OIIArthrogram Tray
- HRXArthroscope
- ITGBandage, Cast
- OIBBlood And Urine Collection Kit (Excludes Hiv Testing)
- OFZBlood Specimen Collection Kit (Excludes Hiv Testing)
- OHHBreast Pump Kit
- OESCardiac Catheterization Kit
- OEZCardiovascular Procedure Kit
- OFFCentral Venous Catheter Tray
- OHMCesarean Section Tray
- OHGCircumcision Tray
- HFWClamp, Umbilical
- NNIContainer, Specimen, Non-Sterile
- OFGCt Biopsy Tray
- OGDCustom Anesthesia Tray
- OGREar, Nose, And Throat Surgical Tray
- NWUEndoscope Introducer Kit
- NWTEndoscopic Cholangiogram Kit
- OGEEpidural Anesthesia Kit
- HNRForceps, Ophthalmic
- OFXGeneral Purpose Dental Tray
- LROGeneral Surgery Tray
- FYAGown, Surgical
- OHDGynecological Laparoscopic Kit
- LRSI.V. Start Kit
- LYVLabel Or Tag, Sterile
- MLSLabor And Delivery Kit
- FDELaparoscopy Kit
- OGHLaryngoscope Kit
- FTALight, Surgical, Accessories
- OGSMyringotomy Procedure Kit
- GAANeedle, Aspiration And Injection, Disposable
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- FMINeedle, Hypodermic, Single Lumen
- MIANeedle, Spinal, Short Term
- OGJNerve Block Tray
- NSBPatient Personal Hygiene Kit
- MLTPelvic Exam Kit
- FTNPlastic Surgery And Accessories Kit
- HIOSampler, Amniotic Fluid (Amniocentesis Tray)
- LRWScissors, General, Surgical
- FPASet, Administration, Intravascular
- HEESet, Anesthesia, Paracervical
- HDFSpeculum, Vaginal, Metal
- FQLStocking, Medical Support (For General Medical Purposes)
- FMGStopcock, I.V. Set
- MCZSuture Removal Kit
- FMFSyringe, Piston
- LJHSystem, Irrigation, Urological
- KGXTape And Bandage, Adhesive
- FCHTray, Biopsy, Without Biopsy Instruments
- FKGTray, Start/Stop (Including Contents), Dialysis
- LRPTray, Surgical
- KNTTubes, Gastrointestinal (And Accessories)
- GAZTubing, Noninvasive
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 184| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2964-2026 | Halyard LAVH PACK, Model/Catalog Number: USAR053-11 | A customer complaint reported that the Clearify Visualization System (5303907) leaked in a kit. As a result of Avid s investigation, it was determined that the component was subjected to EO sterilization which is not in alignment with the manufacturer s recommendation. | Class II | Open, Classified | |
| Z-3011-2026 | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. | Class II | Open, Classified | |
| Z-3010-2026 | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. | Class II | Open, Classified | |
| Z-3009-2026 | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. | Class II | Open, Classified | |
| Z-3008-2026 | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. | Class II | Open, Classified | |
| Z-3007-2026 | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. | Class II | Open, Classified | |
| Z-3006-2026 | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. | Class II | Open, Classified | |
| Z-3005-2026 | Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27 | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. | Class II | Open, Classified | |
| Z-3046-2026 | Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01; 3) ANEURYSM PACK, Model/Item Number (kit) BPAY14-01; 4) SPINE PACK, Model/Item Number (kit) HSLM53-01; 5) ANTERIOR CERVICAL PACK - 205988, Model/Item Number (kit) MHAC65-01; 6) SPINE PACK - 206013, Model/Item Number (kit) MHSP99-01; 7) CRANI PACK, Model/Item Number (kit) WECR41-01. | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products. | Class II | Open, Classified | |
| Z-3045-2026 | 1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINE PACK, (kit) ARMC017; 5) BMHM NEURO PACK, (kit) BMHT016-05; 6) LUMBAR PACK, (kit) BMHT112-03; 7) NEURO LAMINECTOMY PACK, (kit) DGNE75; 8) NEURO LAMINECTOMY PACK, (kit) DGNE75-02; 9) DRAH NEURO LAMINECTOMY SNEDHDN,(kit) DRNE75; 10) DRAH NEURO LAMINECTOMY SNEDHDN, (kit) DRNE75-01; 11) CRANIOSYNOSTOSIS CUSTOM SNE23C, (kit) DUCR36-01; 12) CRANIOSYNOSTOSIS CUSTOM SNE23C, (kit) DUCR36-02; 13) NEURO CRANIOTOMY PK SNE23C1116, (kit) DUNC42-01; 14) PEDS NEURO PACK SNE2301147, (kit) DUNE88-01; 15) NEURO SPINE PACK SNE23LM110, (kit) DUSP98-01; 16) NEURO SPINE PACK SNE23LM110, (kit) DUSP98-02; 17) CRANI PACK 712638, (kit) EFCR86-01; 18) SPINE PACK 712040, (kit) EFSP30-01; 19) SPINE PACK 712040, (kit) EFSP30-02; 20) CRANIOTOMY TRAY, (kit) EURO009-09; 21) CRANI PACK, (kit) IHCR36-01; 22) NEURO PACK, (kit) IHNE35-01; 23) CRANIOTOMY PACK, (kit) JACK410-11; 24) BASIC NEURO PACK, (kit) MAMC275-06; 25) BASIC NEURO PACK, (kit) MAMC275-07; 26) SPINE CRANI PACK, (kit) MCSP92-01; 27) CRANIOTOMY PACK, (kit) MECP05R; 28) SPINE TRAY GLOBALMICROSURG, (kit) MEDF217-02; 29) NEURO BASIC PACK, (kit) MENE06T; 30) CRANIAL PACK - 205992, (kit) MHCP75-01; 31) NEURO PACK, (kit) MMOK007-03; 32) NEURO PACK, (kit) MMTN012-04; 33) CRANIOTOMY PACK SNECGCRM11, (kit) MSMC108-01; 34) NEURO ANT CERV LAMI ADD A PACK, (kit) NAMC413-07; 35) STRL NEURO LUMB LAMI ADD A PK, (kit) NAMC433-05; 36) NEURO CRANI ADD A PACK, (kit) NAMC434-08; 37) NEURO PACK, (kit) NWHR010-03; 38) CRANIOTOMY PACK OSBORN 176518, (kit) OSCR20-01; 39) NEURO PACK, (kit) RDLD001-14; 40) CRANI PACK, (kit) RDLD008-14; 41) NEURO LUMBAR CERVICAL PACK,(kit) SAMM031-18; 42) CRANIOTOMY PACK, (kit) SELF111-02; 43) PELHAM ACDF, (kit) SGAC31-02; 44) PELHAM ACDF, (kit) SGAC31-03; 45) PELHAM MINA SPINE, (kit) SGSP11; 46) PELHAM MINA SPINE, (kit) SGSP11-03; 47) PELHAM SPINE, (kit) SGSP44-02; 48) PELHAM SPINE, (kit) SGSP44-03; 49) SPINE, (kit) SGSP91; 50) SPINE, (kit) SGSP91-02; 51) SPINE, (kit) SGSP91-03; 52) NEURO SPINAL TRAY SHANDS JACKS, (kit) SHND416-02; 53) DR. DELASOTTA NEURO NECK, (kit) SHOR003-15; 54) CRANI PACK, (kit) SLCN72-01; 55) CRANI PACK, (kit) SLCN72-02; 56) CRANI PACK, (kit) SLCN72-03; 57) CRANI PACK - 208400, (kit) UDCP57-01; 58) NEURO TRAY-LF, (kit) UMIA104-11; 59) CRANIOTOMY PACK, (kit) USMA005; 60) CERVICAL NEURO PACK PGYBK, (kit) VAML012-07; 61) LUMBAR NEURO PACK PGYBK, (kit) VAML028-06; 62) NASAL SINUS, (kit) VAPX009-02; 63) LUMBAR LAMINECTOMY TRAY, (kit) VMCC024-14; 64) VA LUMBAR LAMINECTOMY, (kit) VMED009-05; 65) ANTERIOR CERVICAL PACK, (kit) WEAC53-01; 66) CRANI PACK, (kit) WECR41-01; 67) LUMBAR LAMINECTOMY PACK,67) LUMBAR LAMINECTOMY PACK, Model/Item Number (kit) WELL73-01; 68) LUMBAR LAMINECTOMY, (kit) WKMC114-03; 69) CRANIOTOMY PK, (kit) WKMC125-03; 70) DISKECTOMY PACK, (kit) WRNM030-21. | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products. | Class II | Open, Classified | |
| Z-3044-2026 | Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit) ACEN89-02; 3) BACK PACK, Model/Item Number (kit) ALBK51-01; 4) DR DERIAN SPINE PACK SNEDHCPDH, Model/Item Number (kit) DGSP71; 5) BASIC PACK DR BROWN SBADHBPR16, Model/Item Number (kit) DRBS37; 6) BASIC PACK DR BROWN SBADHBPR16, Model/Item Number (kit) DRBS37-01; 7) NASAL PACK SEN23SNRC3, Model/Item Number (kit) DRNS92; 8) NASAL PACK SEN23SNRC3, Model/Item Number (kit) DRNS92-01; 9) NASAL PACK SEN23SNRC3, Model/Item Number (kit) DRNS92-02; 10) SPINE PACK DR BROWN SNEDHSPR14, Model/Item Number (kit) DRSP26; 11) SPINE PACK DR BROWN SNEDHSPR14, Model/Item Number (kit) DRSP26-01; 12) SPINE PACK DR BROWN SNEDHSPR14, Model/Item Number (kit) DRSP26-02; 13) SPINE DR HEYS PACK SNE23SSRCT, Model/Item Number (kit) DRSP52; 14) SPINE DR HEYS PACK SNE23SSRCT, Model/Item Number (kit) DRSP52-01; 15) OHN LARYNGOSCOPY PACK SEN23BRD, Model/Item Number (kit) DULY32; 16) OHN LARYNGOSCOPY PACK SEN23BRD, Model/Item Number (kit) DULY32-01; 17) MICRO FLAP PK SEN23EN14T, Model/Item Number (kit) DUMF13-01; 18) MICRO FLAP PK SEN23EN14T, Model/Item Number (kit) DUMF13-02; 19) OHN NASAL PROCEDURE PACK SEN23, Model/Item Number (kit) DUNS94; 20) OHN NASAL PROCEDURE PACK SEN23, Model/Item Number (kit) DUNS94-01; 21) ORTHO POSTERIOR SPINE PK SOP23, Model/Item Number (kit) DUPS11-01; 22) ORTHO POSTERIOR SPINE PK, Model/Item Number (kit) DUPS11-02; 23) TRAM PACK SBA95TPDU6, Model/Item Number (kit) DUTM67-01; 24) SPINE PACK 176537, Model/Item Number (kit) DVSP33J; 25) LAMINECTOMY PACK, Model/Item Number (kit) EAMC108-03; 26) OMFS PACK, Model/Item Number (kit) EAMC124; 27) SINUS PACK 711866, Model/Item Number (kit) EFSN20-01; 28) KIT,SPINE, Model/Item Number (kit) EUOR004-04; 29) SPINE PACK 176556, Model/Item Number (kit) HOSP20I; 30) LAMINECTOMY PACK, Model/Item Number (kit) JACK401-07; 31) LAMINECTOMY PACK, Model/Item Number (kit) JACK401-08; 32) LAMINECTOMY PACK, Model/Item Number (kit) JACK401-09; 33) SPINE PACK 176476, Model/Item Number (kit) JCSP60F; 34) BACK PACK, Model/Item Number (kit) JEBK01-01; 35) PEDS SINUS PACK, Model/Item Number (kit) LBPS18-01; 36) SINUS PACK, Model/Item Number (kit) LBSN49-01; 37) ORAL SURGERY MAJOR PACK, Model/Item Number (kit) MAMC251-09; 38) SPINE PACK, Model/Item Number (kit) NAFB071-10; 39) SPINE PACK 176524, Model/Item Number (kit) OSSP27-01; 40) ORAL SURGERY HEAD, Model/Item Number (kit) SAMM029-17; 41) LAMINECTOMY PACK, Model/Item Number (kit) SELF112-03; 42) CPT FSC SINUS PACK, Model/Item Number (kit) SHAN415-01; 43) DR. DELASOTTA PLIF, Model/Item Number (kit) SHOR001-15; 44) DELASOTTA MINOR BACK, Model/Item Number (kit) SHOR005-12; 45) SPINE PACK, Model/Item Number (kit) SLCR80-01; 46) DIEP PACK, Model/Item Number (kit) SLDP19-01; 47) SPINE PACK - MAJOR, Model/Item Number (kit) SPST001-06; 48) ESS TRAY, Model/Item Number (kit) SWMR011-02; 49) SPINE PACK 176547, Model/Item Number (kit) TPSP14-01; 50) LAMINECTOMY PACK, Model/Item Number (kit) VALD009-08; 51) EENT PACK, Model/Item Number (kit) VALV225-02; 52) NEURO PACK, Model/Item Number (kit) VAST008-10; 53) SPINAL FUSION, Model/Item Number (kit) WRNM033-22. | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products. | Class II | Open, Classified | |
| Z-2772-2026 | Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit. | Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage. | Class II | Open, Classified | |
| Z-2763-2026 | Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit. | Incorrect concentration of Betadine solution contained within certain AVID convenience kits. | Class II | Open, Classified | |
| Z-2798-2026 | Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05 | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels. | Class I | Open, Classified | |
| Z-2797-2026 | Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15 | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels. | Class I | Open, Classified | |
| Z-2796-2026 | Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05 | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels. | Class I | Open, Classified | |
| Z-2410-2026 | Halyard, Eye Bag Pack. Kit Code: UIEB48-01. | Inadvertent distribution of sealed pouches that had not undergone validated sterilization. | Class II | Open, Classified | |
| Z-2409-2026 | Halyard, Drape Pack. Kit Code: LMDP36-01. | Inadvertent distribution of sealed pouches that had not undergone validated sterilization. | Class II | Open, Classified | |
| Z-2408-2026 | Halyard, Towel Six Pack. Kit Code: AMTS70-01. | Inadvertent distribution of sealed pouches that had not undergone validated sterilization. | Class II | Open, Classified | |
| Z-2407-2026 | Halyard, Pain Pack. Kit Code: AMPK48-01. | Inadvertent distribution of sealed pouches that had not undergone validated sterilization. | Class II | Open, Classified | |
| Z-1979-2026 | Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | Class I | Open, Classified | |
| Z-1978-2026 | Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | Class I | Open, Classified | |
| Z-1977-2026 | Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | Class I | Open, Classified | |
| Z-1976-2026 | Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | Class I | Open, Classified | |
| Z-1975-2026 | Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | Class I | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain