119 results · 29ms · 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.

HEALTHPAK X-RAY SOX BARRIERS

FDA 510(k)
FDA Class 2 ·Dental

75H - PG&E Class B 21 BBP

FDA UDI
Certified Safety Manufacturing, Inc.·00766588233079·PG&E Class B 21 BBP - 75H

Instrument Case

FDA UDI
KATENA PRODUCTS, INC.·00841668111062·INSTRUMENT CASE MEDIUM ALUMINUM

MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

NUVASIVE NVM5 SYSTEM

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

RADIFOCUS GLIDEWIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018

SCREW

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·January 22, 2013

STARCLOSE SE VASCULAR CLOSURE SYSTEM

FDA Adverse Event
Injury ·AV-REDWOOD CITY·Product code MGB·December 13, 2010

TENDRIL ST

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014

EndoVive 3s Low Profile Balloon Kits Part Number: M00548660 (XMD P/N 70-0050-118) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

FDA Enforcement
Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

PROTAPER H-U ASS.21MM *NOT CE*

FDA Adverse Event
Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·April 1, 2026

RADIFOCUS GLIDEWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·December 29, 2025

RADIFOCUS GLIDEWIRE

FDA Adverse Event
Injury ·TERUMO MEDICAL CORPORATION·Product code DQX·May 16, 2024

RADIFOCUS GUIDEWIRE M

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 21, 2021

RADIFOCUS GLIDEWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·October 6, 2025

RADIFOCUS GUIDEWIRE M

FDA Adverse Event
Injury ·TERUMO MEDICAL CORPORATION·Product code DQX·September 15, 2023

GUIDE WIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 25, 2025

RADIFOCUS GUIDEWIRE

FDA Adverse Event
Injury ·TERUMO MEDICAL CORPORATION·Product code DQX·December 5, 2023

RADIFOCUS GUIDEWIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·April 3, 2018

RADIFOCUS GUIDEWIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 23, 2026