9 results · 24ms · Sources: EU EUDAMED, 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