9 results
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18ms
·
Sources: EU EUDAMED, US FDA
VIRAPURE, CHLAMYPURE AND MYCOPURE
FDA 510(k)
FDA Class 1
·Microbiology
HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AXIOM TOTAL KNEE SYSTEM, A/P CURVED TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080120 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
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·December 6, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 5, 2014
EPIC II CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·December 7, 2012
PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080121 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
PKG, RING HANDLE, P/N 0250080236. 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