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

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MICROMANIPULATOR SET

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ArgenPMMA 98x20-B1

FDA UDI
ARGEN CORPORATION, THE·D818120877·Crown And Bridge, Temporary, Resin

Mini Unicycle™

FDA UDI
Ortho Organizers, Inc.·00190707056810·Mini Unicycle™ .120” Ligature Ties - Neon Blue

COMED K-SERIES MANUAL WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

EXCELLITE TURBO LIGHT CURE UNIT

FDA 510(k)
FDA Class 2 ·Dental

GMK-HINGE FIXED TIBIAL TRAY SIZE 1 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·March 31, 2022

M2A-MAGNUM MOD HD SZ 50MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 20, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 11, 2011

ASANTE SNAP INSULIN PUMP SYSTEM

FDA Adverse Event
Injury ·ASANTE SOLUTIONS INC.·Product code LZG·August 11, 2014

VERSE POLY DRIVER SHAFT NAV

FDA Adverse Event
Malfunction ·DEPUY SPINE INC·Product code OLO·April 29, 2022

Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

FDA Enforcement
Class I ·Ongoing·Covidien·November 8, 2023

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