11 results
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18ms
·
Sources: EU EUDAMED, US FDA
MERIDIAN ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Power-Trialysis Slim-Cath catheter
FDA UDI
Bard Access Systems, Inc.·00801741107252·12Fr Trialysis ST 24cm Kit
Zenysis Dual Lumen Acute Dialysis Catheter
FDA UDI
Bard Access Systems, Inc.·00801741109768·Zenysis DL, 24cm ST Kit
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690185420·Revision Knee Spiral Reamer- Hudson Short Flute...
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11 X 360MM X 12
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 6, 2012
Styrker OrthoMap Express Knee System
FDA 510(k)
FDA Class 2
·Neurology
DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTH CORPORATION·Product code FRN·January 23, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 30, 2012
FOUNDATION KNEE
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JWH·September 30, 2010
Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 2020