30 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Hexanium® TLIF
FDA 510(k)
FDA Class 2
·Orthopedic
BI-METRIC XR-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304650619·
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868240089·
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304555242·
ANDREWS PYNCHON SUCTION TUBE
FDA UDI
SONTEC INSTRUMENTS, INC.·B0991804370·ANDREW PYNCHON SUCTION TUBE CHROME
BI-METRIC XR-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304650282·
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF
FDA 510(k)
FDA Class 2
·Neurology
PLEURX LOCKABLE DRAINAGE LINE SET
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·April 2, 2026
CANNULATED SCREW MEASURING DEVICE FOR 3.5MM AND 4.0MM
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HTJ·October 17, 2014
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 27, 2011
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 3, 2026
ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.
FDA Adverse Event
Injury
·AESCULAP AG·Product code NKB·December 21, 2018
ENNOVATE POLYAX.SCREW 7.5X40MM FENESTR.
FDA Adverse Event
Injury
·AESCULAP AG·Product code NKB·December 21, 2018
PLEURX DRAINAGE KIT 500ML 10/CS
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·July 25, 2025
PLEURX DRAINAGE KIT 1000ML
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·January 20, 2026
PLEURX DRAINAGE KIT 1000ML
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·October 15, 2025
PERITX DRAINAGE BAG KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·December 18, 2025
PLEURX DRAINAGE KIT 1000ML
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·September 18, 2025