9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FACET SCREW SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
CERAMIC FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
ARCHITECT IVANCOMYCIN
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LEH·May 20, 2026
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·September 26, 2014
ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FRN·June 8, 2011
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 19, 2024
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·February 26, 2014