527 results · 32ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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