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

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SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS

FDA 510(k)
FDA Class 2 ·Orthopedic

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450232255·

Scorpio

FDA UDI
Howmedica Osteonics Corp.·07613153992530·Posterior Stabilized Tibial Insert

PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES

FDA 510(k)
FDA Class 2 ·Orthopedic

SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515

FDA 510(k)
FDA Class 2 ·Physical Medicine

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 27, 2024

GORE® TAG® THORACIC ENDOPROSTHESIS

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code MIH·November 9, 2015

GORE® INTRODUCER SHEATH WITH SILICONE PINCH VALVE

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code DYB·November 9, 2015

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 24, 2013

QUADRA ASSURA DR CRT-D

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·September 30, 2014

NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR LTD.·Product code MCM·June 16, 2011

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·July 8, 2019

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·March 6, 2019

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·March 26, 2021

TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.

FDA Enforcement
Class II ·Terminated·Synthes (USA) Products LLC·August 24, 2016

Artis zee multi-purpose, Model Number 10094139

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023

Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

FDA Enforcement
Class II ·Terminated·Senseonics, Inc.·November 6, 2019