8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMC ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
FDA 510(k)
FDA Class 2
·Anesthesiology
AMISTEM H FEMORAL CEMENTLESS STEM SIZE 8 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·November 14, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 4, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
SUMMIT DUOFIX TAP SZ5 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code MEH·June 22, 2011
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015