7 results
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19ms
·
Sources: EU EUDAMED, US FDA
BURN DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
iLet® ACE Pump
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 22, 2013
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 8, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 9, 2014
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024