8 results
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36ms
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Sources: EU EUDAMED, US FDA
CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
PFC SIGMARP STB TB IN 2.5 12.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NJL·July 30, 2024
DigiGuide System
FDA 510(k)
FDA Class 2
·Dental
HAIRMAX LASERCOMB
FDA 510(k)
FDA Class 2
·Physical Medicine
SECOND DEVICE: 7.0MM REVERE DUAL OUTER DIAME
FDA Adverse Event
Injury
·GLOBUS MEDICAL, INC.·Product code NKB·May 20, 2010
V. MUELLER HEMOSTAT
FDA Adverse Event
Malfunction
·CAREFUSION 2200, INC.·Product code HRQ·June 11, 2014
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 8, 2010
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