15 results · 21ms · 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.

DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System

FDA 510(k)
FDA Class 2 ·Orthopedic

DJO SURGICAL

FDA UDI
DJO, LLC·00190446953685·SPECIAL, TURON OFFSET GLENOID IMPACTOR HANDLE, ...

Blade Handle

FDA UDI
KATENA PRODUCTS, INC.·00841668112380·BARD-PARKER HANDLE #3

DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100

FDA 510(k)
FDA Class 2 ·Cardiovascular

POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

AMPLATZER SEPTAL OCCLUDER

FDA Adverse Event
Injury ·AGA MEDICAL CORPORATION·Product code MLV·October 11, 2018

WALLFLEX DUODENAL

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MUM·January 22, 2025

COCR HEAD 28/+4 'L' 12/14

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code MEH·January 26, 2026

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014

INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·June 27, 2013

WILLIAMS CYSTOSCOPIC INJECTION NEEDLE

FDA Adverse Event
Injury ·COOK UROLOGICAL, INC.·Product code KOG·August 4, 2011

bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

FDA Enforcement
Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

WALLFLEX COLONIC

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 18, 2024

WALLFLEX COLONIC

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 31, 2024

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021