11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
N/A
FDA UDI
inomed Medizintechnik GmbH·EINO2308869·Universal guide Tube MicroDrive for micro and D...
BD BBL™ Sensi-Disc™ Novobiocin 5 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902308867·BD BBL™ Sensi-Disc™ Novobiocin 5 µg
NICO WITH MARS, MODEL 7300
FDA 510(k)
FDA Class 2
·Anesthesiology
GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD SYRINGE 5ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 13, 2026
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·November 6, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·December 12, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024