11 results
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18ms
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Sources: EU EUDAMED, US FDA
AMPCO SKIN SCRUB TRAYS, CAT.#SS843
FDA 510(k)KETAC-CEM IN REF. TO K802048
FDA 510(k)
FDA Class 2
·Dental
PELVEX HOMETRAINER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CARRIAZO-PENDULAR MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
80FRN
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 4, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 23, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 16, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025