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

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Rampart One Lumbar Interbody Fusion Device

FDA 510(k)
FDA Class 2 ·Orthopedic

BIOMET HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304256668·

Biomet® Hip System

FDA UDI
Biomet Orthopedics, LLC·00887868308345·

MODIFICATIONS TO CD HORIZON SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)

FDA 510(k)
FDA Class 1 ·General Hospital

MALLORY/HEAD RADIAL ACETABULAR SHELL

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LZO·August 2, 2017

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 11, 2013

ACRYSOF RESTOR

FDA Adverse Event
Other ·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·June 10, 2011

ASCENSIA ELITE XL

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·September 9, 2008

BD DISCARDIT¿ II SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 6, 2018

BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code GIM·June 14, 2024

Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.

FDA Enforcement
Class III ·Terminated·Biomet, Inc.·June 17, 2015