7 results
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19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUTO SUTURE(R) ENDOSCOPIC LDS(TM) LIGATING DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SEMPERMED SURGEON'S GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TSRH SACRAL L-CONNECTOR
FDA 510(k)
FDA Class 2
·Orthopedic
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 28, 2014
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·January 9, 2013
ACCUSOL 35 5L ACCUMOON(CZ/POL/SK/UK/IRL)
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CASTLEBAR·Product code KPO·November 23, 2010
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015