8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CEREC Cercon 4D CAD/CAM Blocks
FDA 510(k)
FDA Class 2
·Dental
LCP
FDA UDI
Synthes GmbH·10886982168429·LCP® VOLAR DISTAL RADIUS PLATE EXTRA-ARTICULAR/...
Restoration Anatomic Shell
FDA 510(k)
FDA Class 2
·Orthopedic
AMERICAN DENTAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 11, 2014
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
ROTALINK? PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MCX·July 23, 2013
PKG, ALLIGATOR FORCEPS, P/N 0250080316. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014