11 results · 20ms · Sources: EU EUDAMED, 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