First To Know Syphilis Test

FDA 510(k)

FDA Class 2 ·Microbiology

EEVA 2.0

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Cue COVID-19 Molecular Test

FDA 510(k)

FDA Class 2 ·Microbiology

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

PROLONG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UROLIFT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surfacer Inside-Out Access Catheter System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Analytic for Hemodynamic Instability (AHI)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DentalMonitoring

FDA 510(k)

FDA Class 2 ·Dental

PROSTATE IMMOBILIZER RECTAL BALLOON

FDA 510(k)

FDA Class 2 ·Radiology

CEFALY

FDA 510(k)

FDA Class 2 ·Neurology

Embosphere Microspheres

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190

FDA 510(k)

FDA Class 2 ·General Hospital

Control-IQ Technology

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Masimo SafetyNet

FDA 510(k)

FDA Class 2 ·Anesthesiology

Comfort Marker 2.0.

FDA 510(k)

FDA Class 2 ·Radiology

CYTOSCAN(R) DX

FDA 510(k)

FDA Class 2 ·Immunology

Hearing Aid Feature (HAF)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology