9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ZERO-G
FDA 510(k)
FDA Class 1
·Physical Medicine
Precept
FDA UDI
Nuvasive, Inc.·00887517372017·PRECEPT Rod, 120mm Straight
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192909·12mm X 100mm Stem Pilot
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDERED VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 31, 2014
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 21, 2012
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·September 20, 2010
SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corp.·October 8, 2014