11 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SCHAEDLER SELECTIVE AGAR-KV
FDA 510(k)
FDA Class 1
·Microbiology
BIPLATE SCHAEDLER/SCHAED KV 5% SB 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·June 25, 2021
BD BBL¿ SCHAEDLER K-V AGAR WITH 5% SHEEP BLOOD
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·August 2, 2021
BIPLATE SCHAEDLER/SCHAED KV 5% SB 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·July 1, 2021
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110683·LUER ADAPTOR FOR IRRIGATION
MONITOR, PATIENT (MODEL 78333A)
FDA 510(k)
FDA Class 2
·Cardiovascular
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
FDA 510(k)
FDA Class 2
·Dental
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 21, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·September 26, 2012
CE INFUSOR LV 5, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 19, 2010
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014