7 results
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26ms
·
Sources: EU EUDAMED, US FDA
ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE
FDA 510(k)
FDA Class 2
·Ophthalmic
ARTERIAL EMBOLECTOMY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
JAKOBI SURG. INSTRUMENTS #12 40/41
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 2, 2014
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·November 25, 2012
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS INNOVATION CENTER-SILICON VALLEY·Product code GEX·September 13, 2010
PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267. 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