16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex FastThread Interference Screw
FDA 510(k)
FDA Class 2
·Orthopedic
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197537100·Titanium Eufrat Pasque Needleholder
diamon...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197537117·Titanium Eufrat Pasque Needleholder
diamon...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197537124·Titanium Eufrat Pasque Needleholder
diamon...
FEMVUE CORNUAL BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COVIDIEN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024
COVIDIEN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·January 28, 2026
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·April 26, 2022
ENDOVIVE? STANDARD PEG KIT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·October 17, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 20, 2013
SOFTHEAT
FDA Adverse Event
Other
·KAZ, INC.·Product code IRT·July 21, 2011
HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·February 25, 2019
HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·February 25, 2019
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020