11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYLFIRM X
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STERILE TRAC SYSTEM 12 PACK
FDA UDI
BIOMET MICROFIXATION, INC·00841036199029·
STERILE TRAC SYSTEM 12 PACK
FDA UDI
BIOMET MICROFIXATION, INC·00888233021043·
AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A
FDA 510(k)
FDA Class 2
·Radiology
INCARE PELVIC FLOOR THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RINGLOC ACETABULAR LINER 32MM/ 10 DEGREE SIZE 24
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·June 7, 2017
HEMOSPHERE FORESIGHT MODULE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MUD·February 26, 2026
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·September 25, 2014
MEDISENSE OPTIUM
FDA Adverse Event
Injury
·Product code NBW·August 16, 2011
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013
Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·July 24, 2019