11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DYMAX PERSONAL SCANNER
FDA 510(k)
FDA Class 2
·Radiology
LEONE SPA
FDA UDI
LEONE SPA·08033707059011·DB TUBE EXTREMO NO-Ni 22 T-20 R+8 LL
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862127220·Standard Band, Tooth 45/35, Size 27/Roth 22
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862127180·Standard Band, Tooth 45/35, Size 27/Roth 18
MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP)
FDA 510(k)
FDA Class 2
·Cardiovascular
Bencox M Stem Lateralized & Bencox Mirabo Cup System
FDA 510(k)
FDA Class 2
·Orthopedic
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·September 27, 2023
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 22, 2014
CONFIENT
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 8, 2010
ARTICUL/EZE BALL 32 +1 GR
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 7, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012