11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
FDA 510(k)
FDA Class 2
·Microbiology
artegral life
FDA UDI
Merz Dental GmbH·D7091993319·anteriors; shade C1; mould UBXL
CLEARVIEW HCG DEV(URINE)20T
FDA Adverse Event
Malfunction
·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code JHI·June 22, 2024
XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
FDA 510(k)
FDA Class 2
·Ophthalmic
NUVASIVE VUEPOINT OCT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CLEARVIEW HCG DEV(URINE)20T
FDA Adverse Event
Malfunction
·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code JHI·June 6, 2025
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·March 7, 2013
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·August 8, 2014
FIXODENT HYGIENE(CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE GUM 20%) CREAM 1APPLIC
FDA Adverse Event
Other
·PROCTER & GAMBLE MFG. GMBH·Product code KOO·February 4, 2011
ALERE HCG CASSETTE
FDA Adverse Event
Malfunction
·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code JHI·May 25, 2023
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026