12 results · 19ms · Sources: EU EUDAMED, US FDA

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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