11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Distinct® Early Detection Pregnancy Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AGXO
FDA UDI
Oticon A/S·05707131341181·G200, BTE 13 PP 2.4G 105 C063 AGXO
CHIMAERA Hip Fracture System
FDA UDI
ORTHOFIX SRL·18056099649254·DISTAL SCREWDRIVER RETENTION ROD - SHORT
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198192·AK3 PS Insert Trial Size 3, 18mm
VENTRICULAR CATHETER ACCESSORY KIT (VCAK)
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCICENCS IMPLANTS SA·Product code JXG·May 16, 2016
UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
ACCELERATOR APS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 26, 2011
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 27, 2013
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·July 18, 2018