8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABRASIVE DISC - POLISHING WHEEL
FDA 510(k)
FDA Class 1
·Dental
MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
UTS Stem
FDA 510(k)
FDA Class 2
·Orthopedic
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·June 13, 2014
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWY·December 13, 2012
HUDSON ADULT HEATED-WIRE CIRCUIT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZO·October 12, 2010
NECK FIX ANTI-ROTATION SCR L90 TAN
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·November 26, 2019
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024