10 results
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25ms
·
Sources: EU EUDAMED, US FDA
Embryo Predict
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813035429·Reamers With Silicone Stops21MM #20
Oticon
FDA UDI
Sbo Hearing A/S·05714464089604·OTICON JET 1 MINIRITE T C090
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154629558·Z-PLATE, SMALL, LEFT
Tissue Removal Pouch
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Infrared Body Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
UNK PRODUCT - LEFT TOTAL HIP - CERAMIC
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS CORK·Product code LZO·December 1, 2008
INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOL
FDA Adverse Event
Death
·DRAGER MEDICAL GMBH·Product code MHX·September 14, 2011
JARIT
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORPORATION·Product code GEI·May 28, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013