81 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
N/A
FDA UDI
Tyber Medical, LLC·M695M1304230·
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137336·Broach, 42 X 32, 19mm Height 7° Lordosis
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137305·Broach, 42 X 32, 13mm Height 7° Lordosis
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137329·Broach, 42 X 32, 17mm Height 7° Lordosis
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137299·Broach, 42 X 32, 11mm Height 7° Lordosis
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137312·Broach, 42 X 32, 15mm Height 7° Lordosis
POWERLITE 600 EP SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DERMABOND NX ADHESIVE MODEL: DNX6, DNX12
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OLYMPUS EMPOWER H65
FDA Adverse Event
Malfunction
·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 24, 2013
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
KENSTONE METAL·Product code ITJ·September 30, 2014
OPTIVANTAGE DH
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM BUSINESS·Product code IZQ·June 14, 2011
INSPIRE 6F
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·October 28, 2025
RESERVOIR INSPIRE 8
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 8, 2026
CAPIOX RX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DTZ·May 26, 2023
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·December 18, 2025
INSPIRE HARD VENOUS RESERVOIR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·July 25, 2022
INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code DTZ·January 13, 2023