8 results
·
24ms
·
Sources: EU EUDAMED, US FDA
PRO-PAK FOR OMS DIPLOMATE
FDA 510(k)
FDA Class 2
·Ophthalmic
Valved Safety Centesis Catheter
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS
FDA 510(k)
FDA Class 2
·General Hospital
LIBERTY CYCLER
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·June 13, 2014
PFC*LINER 28MM/ 54-58MM,20 DEG
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 8, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 6, 2011
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·April 18, 2018
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code KQO·November 10, 2017