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

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Biofeedback Nerve and Muscle Stimulator

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

KeyPrint

FDA UDI
Keystone Industries·H66842201611·KeySplint Soft Clear Resin ,1kg

NA

FDA UDI
Smith & Nephew, Inc.·23596010103868·Stainless Steel TROCANTERIC WIRE ...

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112960·CORNEAL TREPHINE BLADE8.75MM

CERTAIN® GOLD-TITE® HEXED SCREW

FDA Adverse Event
Malfunction ·BIOMET 3I·Product code NHA·April 17, 2019

ALPHAPOINT IMAGING SOFTWARE

FDA 510(k)
FDA Class 2 ·Radiology

AGILTRAC .018 PERIPHERAL DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·November 3, 2014

STANDARD CONSOLE W/IRRIGATION FOR ELECTRIC PEN

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code DZI·August 16, 2011

RIATA ST ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.

FDA Enforcement
Class II ·Terminated·Philips Electronics North America Corporation·August 10, 2016

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

FDA Enforcement
Class II ·Terminated·Unomedical As·July 1, 2015

Model Number L111, ESSENTIO DR SL MRI Pacemaker

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