7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
TROCAR AND CANNULA ACCESSORY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DISPOSABLE MONOPLAR MEDDLE ELECTRODES
FDA 510(k)
FDA Class 1
·Neurology
CLEARVIEW HCG SERUM/URINE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BENDING TEMPLATE CALCANEAL PLATE 50MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·January 4, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 21, 2014
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 4, 2011
PKG, 3MM INSERT, FUNDUS GRASPER, 29CPKG, 3MM INSERT, ALLIGATOR GRASPER, 29CM, P/N 0250282051 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