12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Sherpa Pak Cardiac Transport System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MANHATTAN SEVERIN TISSUE FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896015852·MANHATTAN-SEVERIN TISSUE FORCEPS WITH TYING PLA...
Manhattan Severin Tissue Forceps
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896113091·Manhattan Severin Tissue Forceps With Tying Pla...
LIBERTY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CMAP PRO
FDA 510(k)
FDA Class 2
·Physical Medicine
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 22, 2022
UNKNOWN PELVICOL PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·May 24, 2013
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 23, 2014
AIRIS II
FDA Adverse Event
Injury
·HITACHI MEDICAL CORPORATION·Product code LNH·June 23, 2011
PKG, 3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS, 20CM, P/N 0250282000 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
PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 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
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