15 results · 26ms · Sources: EU EUDAMED, US FDA

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Orthodontic Screw

FDA 510(k)
FDA Class 2 ·Dental

PARIE TENE PROGRIP MESH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER

FDA 510(k)
FDA Class 2 ·General Hospital

THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

FDA Adverse Event
Malfunction ·THORATEC CORPORATION·Product code DSQ·October 25, 2024

CONTOUR TS

FDA Adverse Event
Injury ·BAYER HEALTHCARE LLC·Product code NBW·July 8, 2011

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

SYNCHORMED II

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·September 15, 2008

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·May 17, 2019

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·March 18, 2019

OPTILITE SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·June 5, 2020

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·March 12, 2019

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·March 18, 2019

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Injury ·COOK INC·Product code GEX·November 4, 2022

OPTILITE SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·February 13, 2020

Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. 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