9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
FDA 510(k)
FDA Class 1
·General Hospital
Serranator PTA Serration Balloon Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 25, 2022
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·August 8, 2019
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 6, 2014
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·June 17, 2011
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCES LABORATORIES·Product code FTM·July 9, 2013
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026