11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NUTRA LIGHT RED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoRoent
FDA UDI
Nuvasive, Inc.·00887517565785·CoRoent Ant TLIF PEEK, 14x11x30mm 8°
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037176·Unitek(TM) Bicuspid Band General Purpose Wide U...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515018426·Roch-Pean Hemo Fcps, str, 8 3/4"
K2M General Instruments
FDA UDI
VB Spine LLC·10888857580831·Split Tube Retractor Ø20x100 mm
ZYTO HAND CRADLE
FDA 510(k)
FDA Class 2
·Neurology
REMOTENURSE PATIENT MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·June 3, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008
ENDURON 10D 56 OR 68ODX28ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 22, 2011
Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.
FDA Enforcement
Class III
·Terminated·ELITech Group B.V.·October 9, 2019