8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TSRH CENTRAL POST HOOKS
FDA 510(k)
FDA Class 2
·Orthopedic
ARGENCO 52HN
FDA 510(k)
FDA Class 2
·Dental
ROCHE COBAS FUTURA GLUCOSE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SHARPS CONTAINER
FDA Adverse Event
Malfunction
·POST MEDICAL, INC.·Product code FMI·March 12, 2024
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 22, 2013
ADVANTAGE SERIES 26
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code FPO·November 23, 2010
TENDRIL SDX
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item Number HSCY13M; 5) PICC DRESSING CHANGE KIT, Model/Item Number HSDR10K; 6) MIDLINE CHANGE KIT, Model/Item Number HSMD20H; 7) SHOULDER ARTHOSCOPY PACK, Model/Item Number PDSA12D; 8) PDA LF SJW, Model/Item Number SWPD12K; 9) AAA PACK - 206038, Model/Item Number UDAA63AH; 10) BASIC CAB PACK - 206043, Model/Item Number UDBC35AF; 11) BASIC HEART PACK - 206044, Model/Item Number UDBH37AX; 12) FREE FLAP DRAPE PACK (PS 907864), Model/Item Number UIFF72AD; 13) PROCUREMENT PACK, Model/Item Number UIPC89D; 14) THYROID PACK (PS 096552), Model/Item Number UITR45W; 15) TRAUMA PACK 175634, Model/Item Number UMTR17B; 16) TRAUMA PACK 175634, Model/Item Number UMTR17C.
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·September 3, 2025