8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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cryoICE croablation probe
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 6, 2014
UNKNOWN EXTERNAL NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·June 3, 2013
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 28, 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
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024