20 results · 25ms · Sources: EU EUDAMED, US FDA

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Streamline OCT Occipito-Cervico-Thoracic System

FDA 510(k)
FDA Class 2 ·Orthopedic

FATHOM (TM) 14 STEERABLE GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

ALLOFIX ANCHOR, 5.0 MM ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 8, 2024

QUATTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FRN·September 17, 2008

SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code LJS·December 19, 2017

COOK COPE-LOOP CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code LJE·August 23, 2021

ULTRATHANE SUPRAPUBIC CATHETER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code KOB·August 23, 2022

COOK COPE-LOOP CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code LJE·March 17, 2022

COOK COPE-LOOP CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code LJE·March 17, 2022

COOK COPE-LOOP CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code LJE·March 17, 2022

COOK COPE-LOOP CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code LJE·March 17, 2022

HAMILTON MEDICAL AG

FDA Adverse Event
Malfunction ·HAMILTON MEDICAL AG·Product code CBK·January 19, 2024

TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

FDA Adverse Event
Injury ·COOK INC·Product code LJS·October 1, 2018

TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

FDA Adverse Event
Injury ·COOK INC·Product code LJS·October 1, 2018

COOK COPE-LOOP CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code LJE·August 23, 2021

COOK COPE-LOOP CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code LJE·July 21, 2021

Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

FDA Enforcement
Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017