12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776170325·COOLEY-SATINSKY CLAMP .
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780160434·Miltex® Cooley-Satinsky Clamp, 5-1/2", Cardio-G...
Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY
FDA 510(k)
FDA Unclassified
·Unknown
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·August 4, 2017
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 11, 2014
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·September 1, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 23, 2013
UNIV 2-HOLE SHL 48MM LNR SZ 22
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·November 15, 2017
ARCOM 28MM RNGLOC LNR HWALL 22
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·November 15, 2017
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025