12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NOVOKNEE TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131398·TiBase CAM 5.0 .3G E
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575270453·Femoral stem prosthesis trial - General Instrument
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575270460·Femoral stem prosthesis trial - General Instrument
IS-1 HEMOSTASIS VALVE, MODEL 6799
FDA 510(k)
FDA Class 2
·Cardiovascular
STEREOS WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
EQUINOXE CAGE GLENOID XL, POST AUG, RIGHT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·June 19, 2024
BD ULTRA FINE¿ INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·June 1, 2018
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·May 13, 2013
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 16, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014
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