10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARIX Cannulated Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
ECHO BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304463417·
Echo® Bi-Metric® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260780·
VARIOUS
FDA 510(k)
FDA Class 2
·Orthopedic
INSIGHT ULTRASONIC INSERTS
FDA 510(k)
FDA Class 2
·Dental
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·October 7, 2008
NEUROFORM 3 EZ- 4.5 X 30MM
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR CORK·Product code NJE·June 27, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·August 5, 2011
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014