15 results · 29ms · Sources: EU EUDAMED, US FDA

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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