12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAK OSS FEMORAL KNEE COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131393·TiBase CAM 4.3 .3G NE
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575298754·Femoral stem prosthesis trial - General Instrument
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575298761·Femoral stem prosthesis trial - General Instrument
BAYER ADVIA CENTAUR CA 19-9 ASSAY
FDA 510(k)
FDA Class 2
·Immunology
SNAP (R) WOUND CARE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2016
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·UNKNOWN·Product code CAW·October 1, 2014
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·May 13, 2013
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011
BD PHOENIX¿ PMIC/ID-107
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 18, 2024
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016