12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TRANSDUCER, S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·August 8, 2014
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
RHINIX NASAL FILTER
FDA 510(k)
FDA Class 2
·General Hospital
TRANSDUCER, S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·March 28, 2014
TRANSDUCER, S8 3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC·Product code IYO·June 27, 2014
TRANSDUCER S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·January 24, 2014
HDI 5000 ULTRASOUND STANDARD SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 30, 2013
INJECTION GOLD PROBE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code KNS·December 21, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 3, 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