Polyisoprene Extra Large Condom

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Microthin Natural Rubber Latex Condom

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FORTUNE SILICONE VACUUM SUCTION, MODEL #1300

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LifeStyles NRL Textured Condom

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EOS PMP, EOS PMP Integrated

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERFORMER HT/ HANG&GO HT BASIC

FDA 510(k)

FDA Class 2 ·General Hospital

Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use

FDA classification

FDA Class 2 ·Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use

HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

FDA 510(k)

FDA Class 2 ·Medical Genetics

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Medical Genetics

Quantidex qPCR BCR-ABL IS Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

ipsogen JAK2 RGQ PCR Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

FDA 510(k)

FDA Class 2 ·Medical Genetics

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

FDA 510(k)

FDA Class 2 ·Medical Genetics

ipsogen JAK2 RGQ PCR Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

MUTYH-Associated Polyposis (MAP)

FDA 510(k)

FDA Class 2 ·Medical Genetics

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

FDA 510(k)

FDA Class 2 ·Medical Genetics

Helix Laboratory Platform

FDA 510(k)

FDA Class 2 ·Medical Genetics

BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

FDA 510(k)

FDA Class 2 ·Medical Genetics

MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics