12 results · 19ms · Sources: EU EUDAMED, US FDA

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ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH

FDA 510(k)
FDA Class 2 ·Dental

SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1

FDA 510(k)
FDA Class 2 ·Cardiovascular

CLEARVIEW UTERINE MANIPULATOR

FDA Adverse Event
Injury ·CLINICAL INNOVATIONS, LLC·Product code LKF·June 11, 2024

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FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS·Product code DWI·June 12, 2014

UNKNOWN ZIMMER HIP

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JDI·December 21, 2010

PELVILACE TO BIOURETHRAL SUPPORT SYSTEM NEEDLE AND IMPLANT

FDA Adverse Event
Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·January 30, 2013

DHS®/DCS® LAG SCREW 12.7MM THREAD/115MM-STERILE

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·January 22, 2019

GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·July 30, 2014

Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

FDA Enforcement
Class II ·Terminated·Capintec Inc·April 1, 2020

Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021