22 results
·
28ms
·
Sources: EU EUDAMED, US FDA
RELIEEV HSG Catheter (HSG7FA1)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Autoimmune EIA
FDA UDI
BIO-RAD LABORATORIES, INC.·00847817018336·Autoimmune EIA Anti-Tissue Transglutaminase (tT...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192107·Apex Revision Knee Reamer – ZIMMER SHORT FLUTES...
M/DN®
FDA UDI
Zimmer, Inc.·00889024041691·
M/DN®
FDA UDI
Zimmer, Inc.·00889024041677·
M/DN®
FDA UDI
Zimmer, Inc.·00889024041684·
M/DN®
FDA UDI
Zimmer, Inc.·00889024041707·
M/DN®
FDA UDI
Zimmer, Inc.·00889024041653·
M/DN®
FDA UDI
Zimmer, Inc.·00889024041660·
Sensuva Premium Silicone Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SUPERDIMENSION/BRONCHUS 4.1
FDA 510(k)
FDA Class 2
·Radiology
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·November 23, 2005
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·September 18, 2002
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CGA·June 23, 2000
Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.
FDA Enforcement
Class II
·Completed·Bio-Rad Labs·May 6, 2020
IFUSE IMPLANT SYSTEM
FDA Adverse Event
Injury
·SI-BONE, INC.·Product code OUR·November 14, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·September 16, 2011
GYNECARE MORCELLEX TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code HET·July 29, 2013
MEDTRONIC IPG
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVZ·May 24, 2023
MEDTRONIC LEAD
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·May 24, 2023