9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
FLUOROFILM(R)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SeaSpine Spacer System - Ventura™ NanoMetalene®
FDA UDI
Seaspine Orthopedics Corporation·10889981050139·Ventura NM Inserter
ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI
FDA 510(k)
FDA Class 2
·General Hospital
CAPIOX CARDIOTOMY RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 23, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 29, 2013
ANIMAS INSULIN INFUSION PUP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·December 13, 2010
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