8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SARMIENTO FOREARM NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
Patterson
FDA UDI
PATTERSON DENTAL SUPPLY, INC.·D6620708718141·FILE, PULP CANAL, ENDODONTIC
REAGENT CONFIDENCE SERA
FDA 510(k)
FDA Class 2
·Hematology
LIGHT SABRE SPINAL ACCESS DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 17, 2014
FLO-GARD IV SOL. ADMIN SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·October 16, 2010
ASR UNI FEMORAL IMPL SIZE 41
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 13, 2012
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022