13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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