10 results · 19ms · Sources: EU EUDAMED, US FDA

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CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX

FDA 510(k)
FDA Class 2 ·Cardiovascular

TRIMAX

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CORTSCR Ø2 SELF-DRILL L8 TAN

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code MQN·April 29, 2013

PHYSIOMESH

FDA Adverse Event
Injury ·ETHICON·Product code FTL·May 9, 2011

VISI-PRO PTA BALLOON CATHETER

FDA Adverse Event
Injury ·EV3 INC.·Product code FGE·July 24, 2008

STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

FDA Enforcement
Class II ·Terminated·Advanced Sterilization Products·April 10, 2013

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017

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