11 results
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21ms
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Sources: EU EUDAMED, US FDA
ACTRIL FOR KIDNEY MACHINE DISINFECTANT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809641875·OPAQUE MATERNITY 15-20 MM HG THIGH HIGH ZIG ZAG...
OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Wireless Digital Flat Panel Detector
FDA 510(k)
FDA Class 2
·Radiology
M2A MAGNUM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·May 20, 2026
M2A MAGNUM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 20, 2026
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 28, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010
INFUSOMAT SPACE
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·December 4, 2012
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
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