20 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
COBE ACCESSORY INTERFACE MODULE (AIM)
FDA 510(k)
FDA Class 2
·Cardiovascular
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809642919·OPAQUE MATERNITY 20-30 MM HG THIGH HIGH ZIG ZAG...
CoRoent
FDA UDI
Nuvasive, Inc.·00887517158482·CoRoent® XLF, 18x18x60mm
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837012366·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837012427·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837012410·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837012342·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837012403·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837012373·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837012434·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837012359·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837012397·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837012380·
TG-970P CO2 Sensor Kit
FDA 510(k)
FDA Class 2
·Anesthesiology
CLEARFIL MAJESTY ESTHETIC
FDA 510(k)
FDA Class 2
·Dental
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HLTHCARE CORP·Product code FRN·January 13, 2014
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·November 8, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 23, 2015
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 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