16 results · 27ms · Sources: EU EUDAMED, US FDA

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FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)

FDA 510(k)
FDA Class 2 ·Neurology

Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 4, 2025

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 8, 2026

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 29, 2026

DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011

CYLOS DR-T COATED

FDA Adverse Event
Malfunction ·BIOTRONIK GMBH AND CO.·Product code DXY·November 20, 2008

GYNECARE TVT OBURATOR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·July 23, 2013

BALL HEADS: MECTACER 01.29.211 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 26, 2023

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025

CUP: MPACT 01.32.148DH ACETABULAR SHELL Ø48 TWO-HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·October 28, 2022

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 12, 2025

CUP: MPACT ACETABULAR SHELL Ø60 TWO-HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·September 7, 2022

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 21, 2024

ACCOLADE DR SL MRI (Model L311)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025