315 results · 19ms · 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.

MOTION WATCH AND PRO-DIARY

FDA 510(k)
FDA Class 2 ·Neurology

BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

RESOLUTION II CLIP

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

ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.

FDA Enforcement
Class II ·Terminated·OrthoPediatrics Corp·September 10, 2014

PELVILACE BIOURETHRAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·May 16, 2013

20/30 PRIORITY PACK W/COPILOT

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MAV·June 17, 2011

JAGWIRE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code EZB·August 22, 2008

ACCESS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 20, 2015

NMIC-312

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026

PANEL PHOENIX NMIC-312

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026

NI

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 29, 2016

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 8, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026

NI

FDA Adverse Event
Malfunction ·NI·Product code FPA·March 8, 2017

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026

NI

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 24, 2016