23 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
FDA 510(k)
FDA Class 1
·Microbiology
Arthrex®
FDA UDI
ARTHREX, INC.·00888867522114·Cannulated Cancellous Screw, 7.0x120mm
THUNDERBOLT
FDA UDI
Choice Spine, LP·00840996189859·THUNDERBOLT,X-TAB SCREW,5.0X40X120
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981175344·Z-Rod, Dia. 5.5mm, Co-Cr, 120mm
THUNDERBOLT
FDA UDI
Choice Spine, LP·00840996190459·THUNDERBOLT,X-TAB SCREW,6.0X40X120
Toilet Support Arms
FDA UDI
Ropox A/S·05707581000324·
MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S
FDA 510(k)
FDA Class 2
·Orthopedic
PRO-TORQ
FDA 510(k)
FDA Class 1
·Dental
SUPERA SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIP·March 30, 2015
SUPERA SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIP·March 30, 2015
SUPERA SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIP·March 30, 2015
SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG
FDA Adverse Event
Malfunction
·COVIDIEN·Product code NIP·March 14, 2025
HT70 VENTILATOR
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 3, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 5, 2011
PINN MAR +4 NEUT 36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 7, 2008
SUPERA SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code NIP·March 31, 2021
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·September 7, 2022
PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FGE·March 11, 2026
SPINAL ANESTHESIA KIT
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code BSP·November 6, 2018