11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANTI-KERATIN-HMW PRIMARY ANTI-BODY
FDA 510(k)
FDA Class 2
·Immunology
AMPLIVUE GAS ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996
FDA 510(k)
FDA Class 2
·Immunology
BD ALARIS¿ SMARTSITE¿ GRAVITY SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·February 9, 2023
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 18, 2013
ADVANTAGE SERIES 26
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FPO·December 8, 2010
SHEATH TUBE, INSULATED
FDA Adverse Event
RICHARD WOLF GMBH·Product code GCJ·July 8, 2014
BD GEM V/NV 20D 0.2 FLTR
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·July 28, 2022
GEM V/NV NTG 20DP 20PK
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 10, 2020
BD ALARIS¿ SMARTSITE¿ GRAVITY SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·January 20, 2023
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.
FDA Enforcement
Class II
·Terminated·Cook Inc.·July 1, 2015