10 results
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26ms
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Sources: EU EUDAMED, US FDA
WHIRLPOOL BATH MODEL 2273
FDA 510(k)
FDA Class 2
·Physical Medicine
EchoGlo Needle
FDA 510(k)
FDA Class 2
·Anesthesiology
MONITOR, PATIENT, MODEL PM-I0N
FDA 510(k)
FDA Class 2
·Anesthesiology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 25, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 2, 2012
COAGUCHEK S SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JPA·September 18, 2007
REMINGTON MEDICAL DISPOSABLE PACING CABLE
FDA Adverse Event
Malfunction
·REMINGTON MEDICAL·Product code DSA·September 13, 2002
Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·October 3, 2012
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014