8 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517631497·CoRoent Ant TLIF Ti, 14x13x36mm 15°
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Eminent Foot Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·November 26, 2008
TOTAL ASR FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 12, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·July 23, 2013
PKG, 5MM X 33CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250080757 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014