24 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)
FDA Enforcement
Class II
·Ongoing·Abbott Vascular·April 20, 2022
20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
FDA Enforcement
Class II
·Ongoing·Abbott Vascular·April 20, 2022
INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
FDA Enforcement
Class II
·Ongoing·Abbott Vascular·April 20, 2022
LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·March 22, 2017
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·March 22, 2017
20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)
FDA Enforcement
Class II
·Ongoing·Abbott Vascular·April 20, 2022
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·March 22, 2017
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·March 22, 2017
LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·March 22, 2017
N Latex CDT Kit
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·September 5, 2018
Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01)
FDA Enforcement
Class II
·Ongoing·Abbott Vascular·April 20, 2022
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·March 22, 2017
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·March 22, 2017
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·March 22, 2017
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
FDA Enforcement
Class II
·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·May 13, 2015
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
FDA Enforcement
Class II
·Terminated·Vortran Medical Technology 1, Inc·May 24, 2017
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
FDA Enforcement
Class II
·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·March 30, 2016
Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care settings.
FDA Enforcement
Class II
·Terminated·Tecan US, Inc.·September 5, 2018
1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.
FDA Enforcement
Class II
·Terminated·AB ULAX·October 14, 2020
HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
FDA Enforcement
Class II
·Terminated·Ethicon Endo-Surgery Inc·November 25, 2015