18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SHARPS CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000
FDA 510(k)
FDA Class 2
·Anesthesiology
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 6, 2026
PRONOVA BLUE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Death
·ETHICON INC.·Product code GAW·May 7, 2018
PRONOVA BLUE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·May 7, 2018
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 25, 2025
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 6, 2019
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·November 14, 2025
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·July 15, 2025
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 2, 2011
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 14, 2025
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 4, 2026
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·May 26, 2026
Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·March 20, 2013
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