15 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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