13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Juno VPAP ST-A
FDA 510(k)
FDA Class 2
·Anesthesiology
8 CHANNEL CARDIAC PHASED ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
PARTIAL ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HSX·April 20, 2023
PARTIAL ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HSX·July 25, 2022
SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·December 19, 2017
EON MINI
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
HYDRATOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·September 15, 2008
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
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
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