9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOLOX DELTA CERAMIC OPTION HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES
FDA 510(k)
FDA Class 2
·General Hospital
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065631·Corpectomy, 14Dx16Wx53H 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065334·Corpectomy, 14Dx16Wx53H 0°
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·June 27, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
PKG, 5MM X 45CM INSERT, ALLIS FORCEPS, DOUBLE ROW TEETH, P/N 0250080754 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