82 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CRYO-TOUCH II
FDA 510(k)
FDA Class 2
·Neurology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169413665·BLADE 5102021 20MM WIDE VESSELBLADE 21CM
Posifix® -2 Baseplate
FDA UDI
MEDTEC, INC.·00841439100165·Carbon fiber baseplate for five point fixation
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746108365·DB BKT MINI MS UR CEN 022 T+24 A+3 R=0
RHEAD
FDA UDI
Stryker GmbH·00886385025025·Recon Stem Implant Plasma Coated, Size 4
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0120210·Assembly, Screwdriver, Extended Tab, Cannulated...
HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTELLIWAVE3
FDA 510(k)
FDA Class 2
·Ophthalmic
REBAR
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·September 7, 2021
SOLITAIRE FR2
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·September 7, 2021
REBAR
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·September 7, 2021
SOLITAIRE FR2
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·September 7, 2021
IMPLANT SYSTEM, FIBERTAK BUTTON
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code MBI·May 9, 2024
11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FBO·April 1, 2022
11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·May 18, 2022
OPTIFLUX 160NRE DIALYZER FINISEHD ASSY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING·Product code FJI·May 3, 2013
STENOSCOP
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)·Product code JAA·May 18, 2011
COBAS INTEGRA 400
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·August 7, 2008
SYRINGE 1ML LS SP120
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·September 16, 2021
SYRINGE 1ML LS SP120
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·October 13, 2021