12 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RANDOX ALDOLASE CALIBRATION SERUM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EBCHEK BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HYDROCOIL(R) EMBOLIC SYSTEM (HES)
FDA 510(k)
FDA Class 2
·Neurology
PRIMEADVANCED
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·June 1, 2012
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 1, 2012
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 5, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 29, 2013
UNICEL DXC 600 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·May 26, 2011
XIA TITANIUM 4.5 BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code NKB·September 3, 2020
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 4, 2015
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
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015