15 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814183·GENUMEDI PT SILVER L I
MEMO 3D ReChord
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814190·GENUMEDI PT SILVER L II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814206·GENUMEDI PT SILVER L III
CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EUROIMMUN ANTI-SLA/LP ELISA(LGG)
FDA 510(k)
FDA Class 2
·Immunology
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137787·Trial, 42 X 32, 21mm Height 17° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136674·Ti-6Al-4V ALIF Implant 42 X 32, 21mm Height 17°...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138685·Broach, 42 X 32, 21mm Height 17° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523163687·PEEK ALIF Implant 42 X 32, 21mm Height, 17° Lor...
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 29, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 5, 2014
PEEL-AWAY INTRODUCER KIT 6F, .038, 14CM SHEATH
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, AF DIVISION·Product code DTB·May 26, 2011
R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
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