15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEONA 1.5T MRI System
FDA 510(k)
FDA Class 2
·Radiology
HEALIX AWL/TAP
FDA UDI
DEPUY MITEK, LLC·10886705008056·HEALIX Aggressive Awl/Tap 5.5mm
LCP
FDA UDI
Synthes GmbH·10886982156990·LCP(TM) DISTAL FEMUR PLATE 13 HOLES/316MM-LEFT
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 25, 2025
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 30, 2025
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970492·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970485·
Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip
FDA 510(k)
FDA Class 2
·Orthopedic
BLOOD PRESSURE MONITOR WITH STETHOSCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 3, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 12, 2013
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 28, 2023
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·August 20, 2024
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·November 18, 2024