10 results
·
34ms
·
Sources: EU EUDAMED, US FDA
IRON PROCEDURE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809641271·OPAQUE MATERNITY 20-30 MM HG KNEE HIGH ZIG ZAG ...
PALOMAR LUX1540 HANDPIECE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DIAZIR
FDA 510(k)
FDA Class 2
·Dental
RECIPROC FILES 6X
FDA Adverse Event
Malfunction
·VDW GMBH·Product code EKS·September 16, 2024
CONCERTO II CRT-D
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·October 8, 2010
ASPHERE M SPEC 12/14 40 +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·December 7, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
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