12 results · 21ms · Sources: EU EUDAMED, US FDA

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MDT Navigable Brain Biopsy Cannula

FDA 510(k)
FDA Class 2 ·Neurology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526550193·GENUMEDI PT KNEE SUP SILVER R EW IV

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814176·GENUMEDI PT SILVER R I

Thermistor NasalOral, Alice PDx, 220

FDA UDI
Respironics, Inc.·00606959057487·

BD EMERALD SINGLE USE, HYPODERMIC SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

RESTORE ULTRA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 3, 2013

TENDRIL STS

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DTB·January 13, 2014

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 10, 2015

ProScreen 10 Panel Cup, Item No. PSCup-10M

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015

Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

FDA Enforcement
Class II ·Terminated·Ecolab Inc·September 30, 2015

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018