21 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BED BOARD
FDA 510(k)
FDA Class 1
·General Hospital
Spetzler-Malis
FDA UDI
STRYKER CORPORATION·07613327300239·Disposable Slim Bipolar Forceps, Non-Stick,
Malis
FDA UDI
STRYKER CORPORATION·07613327693560·Disposable Slim Bipolar Forceps, Non-Stick,
Spetzler-Malis
FDA UDI
STRYKER CORPORATION·07613327300178·Disposable Slim Bipolar Forceps, Non-Stick,
Spetzler-Malis
FDA UDI
STRYKER CORPORATION·07613327300307·Disposable Slim Bipolar Forceps, Non-Stick,
Malis
FDA UDI
STRYKER CORPORATION·07613327693546·Disposable Slim Bipolar Forceps, Non-Stick,
Malis
FDA UDI
STRYKER CORPORATION·07613327693553·Disposable Slim Bipolar Forceps, Non-Stick,
NEB-U-MASK SYSTEM, MODELS 1895, 1896
FDA 510(k)
FDA Class 2
·Anesthesiology
NEST Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 12, 2007
WIRELESS BATTERY MODULE B
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·January 3, 2014
ENDOTAK ENDURANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 10, 2012
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·November 15, 2023
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·November 15, 2023
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·November 15, 2023
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005
FDA Recall
Open, Classified
·Stryker Corporation·Product code GEI·September 11, 2023
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010
FDA Recall
Open, Classified
·Stryker Corporation·Product code GEI·September 11, 2023
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015
FDA Recall
Open, Classified
·Stryker Corporation·Product code GEI·September 11, 2023
XP-XP Tibial Tray - Interlok 71 mm Item # 195755
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019