13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Scopis Hybrid Navigation System EM
FDA 510(k)
FDA Class 2
·Neurology
UROSKOP OMNIA
FDA 510(k)
FDA Class 2
·Radiology
LAC-MAC INNERBLOC O.R. GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·December 19, 2017
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
LAMITRODE 4
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013
HYDRATOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·September 11, 2008
RESTYLANE KYSSE
FDA Adverse Event
Injury
·GALDERMA Q-MED AB·Product code LMH·June 15, 2020
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
FT3 - FREE TRIIODOTHYRONINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CDP·October 10, 2014
FT4, FREE THYROXINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016
Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 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