15 results
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29ms
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Sources: EU EUDAMED, US FDA
PISTORMATIC
FDA 510(k)
FDA Class 2
·General Hospital
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199267·AK3 PS Notch Reamer Guide Size 4/3+
SurgyCut
FDA UDI
U.S. SURGITECH INC.·00810014631103·SurgyCut J - Hook Hand Control Electrode, 5mm/35cm
discovery®
FDA UDI
DENTAURUM GmbH & Co.KG·J011790104000·discovery® Bracket with hook, - 2° Torque, + 13...
SurgyCut
FDA UDI
U.S. SURGITECH INC.·00810014632124·SurgyCut J - Hook Hand Control Electrode, 5mm/45cm
JHOOK
FDA Adverse Event
Malfunction
·U.S. SURGITECH, INC.·Product code GEI·June 20, 2024
LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System
FDA 510(k)
FDA Class 2
·General Hospital
SURGYCUT
FDA Adverse Event
Malfunction
·U.S. SURGITECH INC·Product code GEI·August 23, 2024
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·May 5, 2014
PROTECTA XT VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 15, 2012
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·August 5, 2010
BD ALARIS¿ EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 24, 2021
UNSPECIFIED BD INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 22, 2022
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025