9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VENTANA BLUE DETECTION KIT
FDA 510(k)
FDA Class 2
·Immunology
AXSOS
FDA UDI
Stryker GmbH·07613327086027·Instrument insert w, tag Ti 4.0mm ORIF Optional
LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESPIRONICS REUSABLE HEATED TUBING
FDA 510(k)
FDA Class 2
·Anesthesiology
OPERATING CYSTOSCOPE-URETHROSCOPE
FDA Adverse Event
Death
·KARL STORZ SE & CO. KG·Product code FGB·March 8, 2023
JUVEDERM (VOLUME/CONCENTRATION UNK)
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·June 18, 2014
UNICEL® DXC 600 SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·February 3, 2013
OCTRODE LEAD KIT 60CM LENGTH
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·December 20, 2010
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020