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