527 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Plasdent Disposable Barrier Sleeves and Barrier Film
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772344123·PROTECT.PRO ACTION BACK SUPPORT BLACK L
NA
FDA UDI
Stryker GmbH·07613154639625·Screw Marker 16,4
Tasso+ Convenience Kit
FDA UDI
Tasso Inc.·00860006434557·Tasso+ convenience kit allows self-collection o...
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383554428·"An absorbent paper points is an endodontic pap...
16PW - Loggers - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015040·16PW - Loggers - Poly White
MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
FDA 510(k)
FDA Class 2
·Neurology
DANA DIABECARE
FDA 510(k)
FDA Class 2
·General Hospital
HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·June 7, 2018
HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·July 19, 2018
HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·July 9, 2018
HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER 2.0
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·March 6, 2018
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·December 2, 2016
HEARTWARE VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·August 17, 2018
HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·July 25, 2018
PROMUS PREMIER¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·December 5, 2016
The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.
FDA Recall
Terminated
·Bio-Rad Laboratories, Inc.·Product code JJX·May 13, 2015
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·February 18, 2016
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·October 27, 2014
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·June 26, 2013