10 results · 18ms · Sources: EU EUDAMED, US FDA

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SCAN WHITE 12 ML

FDA 510(k)
FDA Class 2 ·Dental

VERTEX® Reconstruction System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074239170·BONE SCREW 6955406 4.0 X 6MM CORTICAL

Coulmed

FDA UDI
Coulmed Products Group LLC·10810087350328·Standard Sterile Surgical Gown, with Towel, Lar...

Arthrex®

FDA UDI
ARTHREX, INC.·00888867406544·Trial Humeral Spacer 33 +6mm

DAVOL ELECTROSUGICAL PROBES

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

OSTEONICS HIP REVISION WEDGES

FDA 510(k)
FDA Class 2 ·Orthopedic

CAPSURE Z NOVUS

FDA Adverse Event
Malfunction ·MPRI·Product code DTB·February 11, 2013

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 24, 2014

ACCU-CHEK ® COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·January 10, 2011

Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

FDA Enforcement
Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016