35 results
·
24ms
·
Sources: EU EUDAMED, US FDA
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;
FDA 510(k)
FDA Class 2
·Clinical Chemistry
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198376·AK3 PS Insert Trial Size 6, 11mm
HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PAIN CARE MULTI-PORT CATHETER, MODEL 2000L
FDA 510(k)
FDA Class 2
·General Hospital
UNKNOWN
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·December 16, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·December 16, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·December 16, 2019
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·March 25, 2015
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI MEDICAL TECHNOLOGIES LTD.·Product code FZP·September 2, 2011
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 26, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 6, 2013
ECHO POR FMRL NC 16X160
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·September 16, 2014
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·April 19, 2011
DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·May 24, 2023
EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·November 30, 2021
EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·January 17, 2023
UNKNOWN
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·December 16, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·December 18, 2019
ESW PROSTHESIS, ESOPHAGEAL
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·December 5, 2019
UNKNOWN
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·December 19, 2019