11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REFORM PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131343·TiBase SEV 4.8 1.0G NE
Plateau C
FDA UDI
Life Spine, Inc.·00190837093587·
POWDERED VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
TPSA FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Immunology
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2016
PARIETEX UGYTEX PP POSTERIOR KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTP·May 17, 2013
SAPHIR 3
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NVZ·June 16, 2011
SPRINT FIDELIS
FDA Adverse Event
Malfunction
·MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT·Product code LWS·August 6, 2008
BD PHOENIX¿ PMIC/ID-107
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 18, 2024
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