8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05714464007790·OTICON MORE 2 MINIRITE R C093
VEGA KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)
FDA 510(k)
FDA Class 2
·Orthopedic
COLLEAGUE COLOR PUMP CE FRENCHVERSION TIPLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code FRN·November 4, 2008
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·July 21, 2011
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 9, 2013
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·May 18, 2016