15 results
·
22ms
·
Sources: EU EUDAMED, US FDA
SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AXION 5, MODIFICATION
FDA 510(k)
FDA Class 2
·Neurology
8F BGC 95CM
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code DQY·January 15, 2013
IDENTITY ADX DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 15, 2014
ADVANCE MALE SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·November 30, 2010
RADIFOCUS GLIDECATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·July 14, 2020
RADIFOCUS GLIDECATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·July 3, 2024
RADIFOCUS GLIDECATH
FDA Adverse Event
Injury
·Product code DQO·November 3, 2020
RADIFOCUS GLIDECATH
FDA Adverse Event
Injury
·Product code DQO·November 3, 2020
RADIFOCUS GLIDECATH
FDA Adverse Event
Injury
·Product code DQO·November 3, 2020
NOVATION HIP COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code LPH·July 23, 2025
RADIFOCUS GLIDECATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·January 24, 2023
RADIFOCUS ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·September 26, 2018
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024