7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANGIOMED HIGH PRESSURE CONNECTORS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AxoGen Nerve Cap
FDA 510(k)
FDA Class 2
·Neurology
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROTECTA CRT-D
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·December 10, 2012
STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND GMBH·Product code DWA·June 17, 2015
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