1,384 results
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31ms
·
Sources: EU EUDAMED, US FDA
C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02
FDA 510(k)
FDA Class 1
·Ophthalmic
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809846102·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE EXTRA ...
HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200
FDA 510(k)
FDA Class 2
·Cardiovascular
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
FDA 510(k)
FDA Class 2
·Immunology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 11, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 13, 2011
CIDEX OPA SOLUTION
FDA Adverse Event
Injury
·JOHNSON & JOHNSON·Product code LRJ·May 23, 2008
UNK
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KNS·June 13, 2014
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Injury
·LIVANOVA DEUTSCHLAND·Product code DWC·December 8, 2017
HEATER-COOLER SYSTEM, 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·November 6, 2018
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·January 23, 2019
NONE - SEE PHYSICIAN COMMENTS IN H10.
FDA Adverse Event
Injury
·Product code JWH·October 16, 2013
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·August 8, 2019
TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01
FDA Enforcement
Class II
·Terminated·ArthroCare Corporation·April 13, 2016
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·March 29, 2019
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·February 23, 2017
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·May 10, 2019
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·May 3, 2019
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·June 6, 2019
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·March 7, 2019