8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MIRROR TIP
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
DE48-PLUS
FDA 510(k)
FDA Class 2
·Neurology
INLINE PRECISION VALVE SG, M
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF·Product code JXG·May 21, 2014
DISTAL STEM INSERTER
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·October 10, 2012
ENDOPATH ETS COMPACT FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER FOR OPEN PROCE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·January 16, 2008
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
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021