7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCIPOTEX POWDER FREE SURGICAL GLOVES (UNBEADED)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ELLIPSE LIGHT SPT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Prelude SNAP Splittable Sheath Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
DACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS, INC.·Product code LZG·January 21, 2013
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 31, 2010
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 18, 2014
PKG, NEEDLE NOSE FORCEPS, P/N 0250080288. 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