9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ENDOSCOPE AND ACCOSSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Class B 21 BloodBorne Pathogen - 75H Cabinet
FDA UDI
Certified Safety Manufacturing, Inc.·00766588260044·Class B 21 BloodBorne Pathogen - 75H Cabinet
Arthrex®
FDA UDI
ARTHREX, INC.·00888867138339·RETRACTOR, ANGLED 2 POINTS
PBI MULTILASE D COPPER VAPOR LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIVONA TRACHEAL T-TUBE STENT
FDA 510(k)
FDA Class 2
·Anesthesiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 23, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010
TENDRIL STS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Enforcement
Class II
·Ongoing·Osteomed, LLC·December 15, 2021