8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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1800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODES
FDA 510(k)
FDA Class 2
·Cardiovascular
CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRA WAVE 101
FDA 510(k)
FDA Class 1
·Physical Medicine
TEARDROP HANDLE, AO COUPLING IMPLANT EXTRACTION SE
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 21, 2012
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·February 6, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 21, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 4, 2011
PKG, FUNDUS FORCEPS, P/N 0250080315. 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