17 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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AI-ECG Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304555198·
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868240034·
ANDREWS PYNCHON SUCTION
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896000506·ANDREWS PYNCHON SUCTION STAINLESS STEEL
ANDREWS PYNCHON SUCTION
FDA UDI
SONTEC INSTRUMENTS, INC.·B0991804320·ANDREWS PYNCHON SUCTION STAINLESS STEEL
OLYMPUS EMPOWER H65
FDA Adverse Event
Malfunction
·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022
POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS
FDA 510(k)
FDA Class 2
·General Hospital
MAPERSOL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 27, 2011
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.
FDA Adverse Event
Injury
·AESCULAP AG·Product code NKB·December 21, 2018
ENNOVATE POLYAX.SCREW 7.5X40MM FENESTR.
FDA Adverse Event
Injury
·AESCULAP AG·Product code NKB·December 21, 2018
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022