10 results
·
32ms
·
Sources: EU EUDAMED, US FDA
BIPOLAR ELECTROSURGICAL SNARE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POSTURETEK
FDA 510(k)
FDA Unclassified
·Unknown
VarseoSmile Temp
FDA 510(k)
FDA Class 2
·Dental
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 2, 2013
ADVANTA
FDA Adverse Event
Malfunction
·HILL-ROM INC·Product code FNL·February 15, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 8, 2010
ACHIEVE MAPPING CATHETER - 20 MM
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code DRF·April 4, 2023
ARCTIC FRONT ADVANCE® ST CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code OAE·April 4, 2023
ARCTIC FRONT ADVANCE® ST CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code OAE·April 4, 2023
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