9 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SDI COMPOSTIES
FDA 510(k)
FDA Class 2
·Dental
Pelvic Floor Stimulator (Intrelief PFE)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VECTORVISION UNI-KNEE
FDA 510(k)
FDA Class 2
·Neurology
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 4, 2013
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·December 23, 2010
FREESTYLE
FDA Adverse Event
Malfunction
·Product code LFR·July 17, 2014
HANDLE WITH MINI QUICK COUPLING
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWX·October 10, 2018
ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·January 26, 2018
PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. 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