41 results · 26ms · 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.

PURESLEEP

FDA 510(k)
FDA Class 2 ·Dental

Comprehensive® Shoulder System

FDA UDI
Biomet Orthopedics, LLC·00880304212183·

8920 MASK

FDA UDI
HANS RUDOLPH, INC.·00817136020532·8920 ADULT LG MASK W/2630 2W

Comprehensive Shoulder System

FDA UDI
Biomet Orthopedics, LLC·00880304681019·

CapSure® Spine System

FDA UDI
Spine Wave, Inc.·10840642103984·LP Cross Connector Large

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K1430220·Rod Cutter, Table Top

0113022

FDA Adverse Event
Malfunction ·BURTON MEDICAL PRODUCTS·Product code FQP·August 30, 1996

SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS

FDA 510(k)
FDA Class 2 ·Cardiovascular

KIM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 16, 2026

SUPERIOR END PLATE MEDIUM 6°-STERILE

FDA Adverse Event
Injury ·SYNTHES BRANDYWINE·Product code MJO·May 15, 2013

OCTRODE

FDA Adverse Event
Injury ·ST JUDE MED - NEUROMODULATION·Product code GZB·September 17, 2014

FORCE TRIVERSE ES DEVICE COATED BLADE

FDA Adverse Event
Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·May 25, 2011

HYBRID GLENOID BASE SMALL

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·February 8, 2018

SMALL HYBRID GLENOID BASE 4MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·August 13, 2018

COMPREHENSIVE SHOULDER SYSTEM HYBRID GLENOID BASE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code MBF·September 8, 2025

NEEDLE, HYPODERMIC, SINGLE LUMEN

FDA Adverse Event
Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·September 1, 2020

TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

FDA Adverse Event
Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·August 28, 2018

NEEDLE, HYPODERMIC, SINGLE LUMEN

FDA Adverse Event
Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 8, 2019

PT HYBRID GLEN POST REGENEREX

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·November 2, 2017