11 results
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19ms
·
Sources: EU EUDAMED, US FDA
BBL STREP GROUPING KIT
FDA 510(k)
FDA Class 1
·Microbiology
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665585028·MIS Fenestrated Screw, Ø10.5 x 65mm, Ø5.5mm Rod
Hudson RCI Triflo II Incentive Deep Breathing Exerciser
FDA 510(k)
FDA Class 2
·Anesthesiology
EAV COMBI-2
FDA 510(k)
FDA Class 2
·Neurology
ENTERPRISE2 4MMX39MM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·August 23, 2024
FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SAN JOSE·Product code NFA·December 13, 2010
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·December 7, 2012
ENTERPRISE2 4MMX39MM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·December 12, 2022
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015