8 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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APEX SPX CARDIAL
FDA 510(k)
FDA Class 1
·Radiology
IMMIX PLASTIFILM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
GYNECARE TVT-ABBREVO MINI LCM
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code OTN·November 13, 2018
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 29, 2013
V. MUELLER
FDA Adverse Event
Malfunction
·CAREFUSION·Product code KBN·December 15, 2010
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 14, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024