8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARIX Wrist System
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131340238·SIYA 2, KIT 312 NFM 90 R C001
SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS
FDA 510(k)
FDA Class 2
·Cardiovascular
MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01
FDA 510(k)
FDA Class 2
·Cardiovascular
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014
GLUCOSE MONITORING SYS/KIT
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2013
PROXIMATE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GDT·July 28, 2011
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
FDA Enforcement
Class II
·Ongoing·Cook Vandergrift, Inc.·September 13, 2023