4,136 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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