272 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Black Silicone Filiform Double Pigtail Stent Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 30, 2022
FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 30, 2022
BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 31, 2023
FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 2, 2020
External Fixation
FDA UDI
Life Spine, Inc.·00190837022983·20mm Bolt
Spex
FDA UDI
SPEX LIMITED·09420051701304·Spex 14" wide w/c Padded calf strap
RAUMEDIC ICP MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ULTRALITE PRO MODULE
FDA Adverse Event
Injury
·INTEGRA YORK, PA INC.·Product code FST·January 20, 2017
MCGRATH
FDA Adverse Event
Injury
·AIRCRAFT MEDICAL LIMITED·Product code CCW·October 11, 2019
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 10, 2013
CARDINAL HEALTH-ALARIS PRODUCTS
FDA Adverse Event
Injury
·CARDINAL HEALTH - ALARIS PRODUCTS·Product code FRN·September 22, 2008
ZIPWIRE GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code DQX·September 7, 2006
THV VALVE UNKNOWN
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·September 8, 2017
OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
FDA Enforcement
Class II
·Terminated·Edward Lifesciences, Llc·September 23, 2015
Foot Pack, part number AMS3637
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
FDA Recall
Terminated
·3M Company Health Care Business 3m Center·Product code FLL·October 17, 2017