8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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C-CAT Anaesthesia Catheter kit
FDA 510(k)
FDA Class 2
·Anesthesiology
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
ARTHROSCOPE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code HRX·June 26, 2013
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 25, 2008
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·December 29, 2023
CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015