9 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SHELHIGH BIORING
FDA 510(k)
FDA Class 2
·Cardiovascular
LANX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 20, 2025
ARCHITECT IVANCOMYCIN
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LEH·May 20, 2026
NELLCOR N20
FDA Adverse Event
Malfunction
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code DQA·May 15, 2013
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 15, 2008
Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1121 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·January 15, 2014