11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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The Optilite IgG3 kit
FDA 510(k)
FDA Class 2
·Immunology
BD VACUTAINER® SST¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·September 4, 2025
BD VACUTAINER® SST¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 19, 2025
TAMARIN BLUE PTCA RX DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
FDA 510(k)
FDA Class 2
·Immunology
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 3, 2013
BANTAM FEM HEAD 28MM+0
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code LPH·June 23, 2011
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·August 26, 2008
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015