11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AZLOCILLIN 75MCG SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
Obtura Spartan
FDA UDI
Young Innovations, Inc.·00840326418376·Obtura III Max Heated Gutta Percha System
WRIST AUTOMATIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017
FDA 510(k)
FDA Class 2
·Cardiovascular
RESECTION SHEATH, 24 FR.
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·December 15, 2025
UNIVERSAL MODULAR ECLECTRIC/BATTERY DOUBLT
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL S.A.·Product code GEY·February 20, 2014
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code FZP·December 3, 2007
SHILEY
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code JOH·October 30, 2012
Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.
FDA Enforcement
Class II
·Terminated·Market-Tiers Inc·December 3, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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