9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KENLOR LIQUID URINE CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HEMORRHOIDAL LIGATOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
World Knee Total Knee Systems
FDA 510(k)
FDA Class 2
·Orthopedic
TAPER SLEEVE ADAPTER 12/14 +2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·October 6, 2015
PROXIMA HI OFFSET R SZ 4
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·October 6, 2015
CODMAN EXTERNAL DRAINAGE SYSTEM
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·June 24, 2014
6461500 INFUSOR PUMP (1 LABEL)
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 4, 2010
ETAC SWIFT MOBIL
FDA Adverse Event
Malfunction
·ETAC SUPPLY CENTER AB·Product code INM·November 19, 2012
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012