4,136 results · 25ms · Sources: EU EUDAMED, US FDA

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Dall-Miles® Cable System

FDA 510(k)
FDA Class 2 ·Orthopedic

Greenwald Surgical Company, Inc.

FDA UDI
GRACE MANUFACTURING, INC.·10801334001063·Friedman-Otis Bougie-a-Boule, with 3 (graduated...

SprintRay NightGuard Firm

FDA UDI
Sprintray, Inc.·00850039704161·The material is an alternative to traditional d...

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193113487·HA PEEK EVOS Straight, ,16mmx8mmx 30mm , FLAT ...

10PW - General Purpose

FDA UDI
Certified Safety Manufacturing, Inc.·00766588020129·10PW - General Purpose

POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE

FDA 510(k)
FDA Class 1 ·General Hospital

PHILIPS INTEGRIS ALLURA

FDA 510(k)
FDA Class 2 ·Radiology

QUICKFLEX MICRO LV LEAD

FDA Adverse Event
Death ·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code OJX·February 10, 2017

LAMITRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 17, 2014

SPRINT QUATTRO SECURE S

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

SM104 MSERIES W5TH WHLOBS3/07

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 2, 2013

HEARTWARE® VENTRICULAR ASSIST SYSTEM

FDA Adverse Event
Malfunction ·HEARTWARE, INC·Product code DSQ·January 5, 2017

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code OYC·November 15, 2016

NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR LTD.·Product code MCM·May 20, 2016

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·January 16, 2017

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·January 12, 2017

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 22, 2016

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code OYC·August 22, 2016

GREENLIGHT XPS LASER SYSTEM

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·December 6, 2016