14 results · 39ms · Sources: EU EUDAMED, US FDA

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Skeletal Dynamics Ulnar Shortening Plating System

FDA 510(k)
FDA Class 2 ·Orthopedic

NA

FDA UDI
Synthes GmbH·10886982143280·1.8MM BUTTRESS PIN/12MM

S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY-

FDA 510(k)
FDA Class 2 ·Ophthalmic

OLYMPUS ULTRASONIC SURGICAL SYSTEM

FDA 510(k)
FDA Unclassified ·Unknown

PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code NEW·March 19, 2020

ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAT·March 19, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020

GENESIS

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 17, 2014

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY NELLCO·Product code CBK·June 27, 2013

INTRINSIC

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·July 2, 2019

CONTOUR TRANSTAR STAPLER SET

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 20, 2019

CD HORIZON SOLERA VOYAGER SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 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