15 results · 34ms · 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.

Root Apex Locator

FDA 510(k)
FDA Unclassified ·Unknown

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112991·CORNEAL TREPHINE BLADE16MM

AXS

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327369489·AXS Blade For 6514-7-200, 1.2/1.7

JMS APHERESIS NEEDLE SET WINGEATER(R) V2

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW

FDA 510(k)
FDA Class 2 ·Anesthesiology

BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·August 5, 2021

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 28, 2013

MERIT CUSTOM KIT

FDA Adverse Event
Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·November 16, 2011

MERIT CUSTOM KIT

FDA Adverse Event
Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·November 16, 2011

MERIT CUSTOM KIT

FDA Adverse Event
Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·November 16, 2011

MERIT CUSTOM KIT

FDA Adverse Event
Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·November 16, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 29, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 8, 2013

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025