9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL 2000 OPHTHALMIC SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994128072·CASES 2940084 DL DISTRACTOR TRAY
VARIAX
FDA UDI
Stryker GmbH·07613327083170·Drawer Reduction Instrument
V-STRUT® Vertebral Implant
FDA 510(k)
FDA Class 2
·Orthopedic
LIFESTYLE CIRCULATORY ENHANCER
FDA 510(k)
FDA Class 2
·Anesthesiology
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·December 29, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020