13 results · 21ms · Sources: EU EUDAMED, US FDA

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vatech A9 (Model : PHT-30CSS)

FDA 510(k)
FDA Class 2 ·Radiology

LAURAIN DEWALD ANTERIOR FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ACE AIM TTC FUSION NAIL

FDA 510(k)
FDA Class 2 ·Orthopedic

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·October 14, 2022

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·October 14, 2022

LIGAMAX-5MM ENDO CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·October 10, 2008

INSYNC SENTRY

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

VANGUARD CR MONO-LOCK BEARING 14X79

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 3, 2013

EQUINOXE SHOULDER COMPONENTS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWS·June 27, 2024

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·March 25, 2025

ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

FDA Enforcement
Class I ·Terminated·Oscor, Inc.·July 19, 2017

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021