11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUICK CORE II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150744·K-WIRE - SINGLE TROCAR 2.5mm DIA x 150mm
GDC POWER SUPPLY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - FREMONT·Product code HCG·July 20, 2010
SYNCHRON URIC ACID
FDA Adverse Event
BECKMAN COULTER INC.·Product code KNK·June 10, 2011
OKAMOTO STUDDED CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
JetBoots PRO Plus
FDA 510(k)
FDA Class 2
·Physical Medicine
MALLINCKRODT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code BTR·August 17, 2016
XMAX MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code ERL·January 31, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 16, 2010
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWY·July 17, 2014
PKG, 5MM X 45CM INSERT, ALLIS FORCEPS, DOUBLE ROW TEETH, P/N 0250080754 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