313 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Oxy2Pro
FDA 510(k)
FDA Class 2
·Anesthesiology
FlexiNylon cartridges Amhari/Purple Pink
FDA UDI
PERFLEX LTD·07290110500597·box of 6 identical cartridges sealed in aluminu...
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113713·PS-C Insert, Size 5 x 11mm
FlexiNylon cartridges Amhari/Purple Pink
FDA UDI
PERFLEX LTD·07290110506537·5 identical cartridges sealed in a vacuum bag ;...
Ambassador Cervical Plate System
FDA UDI
Choice Spine, LP·00840996160964·AMBASSADOR,DRILL,2.5x11
AART CALF IMPLANT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASMUTH
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code DRX·November 5, 2008
EZ-PRO 2 AMBUL COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·July 13, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 12, 2013
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·May 27, 2026
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 19, 2026
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 19, 2026
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 19, 2026
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 19, 2025
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 19, 2025
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 21, 2026
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·July 8, 2015
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC) -
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 3, 2024