10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
HUMAN SERUM - STERILE FILTERED
FDA 510(k)
FDA Class 1
·Hematology
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809642551·OPAQUE MATERNITY 20-30 MM HG THIGH HIGH ZIG ZAG...
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177218·Modular Trial, 16 x 14 x 12mm, 7 Deg Lordosis
Bose SoundControl Hearing Aid
FDA UDI
BOSE CORPORATION·00017817827416·A self-fitting wireless air conduction hearing ...
Freedom Syringe
FDA 510(k)
FDA Class 2
·General Hospital
COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005
FDA 510(k)
FDA Class 2
·Clinical Chemistry
REVEAL XT
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·June 10, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 7, 2012
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010
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