10 results
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18ms
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Sources: EU EUDAMED, US FDA
ALCOHOL PAD
FDA 510(k)
FDA Class 2
·General Hospital
Pads
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761968899·Pad TTS Carbon one part G
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761975958·Trumpf Medical/Medizin Pad TTS Carbon one part G
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TETHER ACFS
FDA 510(k)
FDA Class 2
·Orthopedic
ALIGN TO URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code FTL·April 24, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 6, 2011
SYNOX SX 53-BP
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·July 21, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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