8 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD Intraosseous Vascular Access System EMS Powered Driver (D001003)
FDA 510(k)
FDA Class 2
·General Hospital
LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CERANUM 90
FDA 510(k)
FDA Class 2
·Dental
TARGET 360 SOFT 4MM X 8CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR CORK·Product code HCG·November 4, 2014
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 12, 2011
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 10, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018