21 results · 23ms · Sources: EU EUDAMED, US FDA

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NORMATEC MVP

FDA 510(k)
FDA Class 2 ·Physical Medicine

4900 7L SYRINGE

FDA UDI
HANS RUDOLPH, INC.·00817136020389·4900 7L CAL SYR W/REV MARK ROD

FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)

FDA 510(k)
FDA Class 2 ·General Hospital

DUO-VENT CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 29, 2022

GMK FEMORAL CUTTING GUIDE 4INL SIZE 4

FDA Adverse Event
Other ·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2013

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·October 31, 2022

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 1, 2022

NI

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FPA·October 3, 2016

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 26, 2025

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 16, 2020

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 16, 2020

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013

TEGRESS URETHRAL IMPLANT

FDA Adverse Event
Injury ·C.R. BARD, INC. (COVINGTON)·Product code FBK·September 17, 2014

AFFINITY

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code HDD·May 25, 2011

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 14, 2020

BLAKE DRAIN UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GBX·March 6, 2018

Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.

FDA Enforcement
Class I ·Terminated·Brainlab AG·January 27, 2016

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L231, PROPONENT DR EL MRI Pacemaker

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