82 results · 21ms · Sources: EU EUDAMED, 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