272 results · 23ms · Sources: EU EUDAMED, 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