8 results
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18ms
·
Sources: EU EUDAMED, US FDA
VITALON CHAIR MASSAGER MODEL V-CHR2
FDA 510(k)
FDA Class 1
·Physical Medicine
Medline Electrocautery Pencil
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CENTRIFICHEM FILTER CALIBRATION SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRAM 450
FDA Adverse Event
Injury
·GE HEALTHCARE·Product code MHX·June 2, 2014
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·October 25, 2010
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 21, 2012
VERSYS FEMORAL HEAD
FDA Adverse Event
Injury
·ZIMMER, TURPEAUX INDUSTRIAL PARK·Product code JDI·March 31, 2016
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