Notal Vision Home Optical Coherence Tomography (OCT) System

FDA 510(k)

FDA Class 2 ·Ophthalmic

ClearMate

FDA 510(k)

FDA Class 2 ·General Hospital

23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia

FDA 510(k)

FDA Class 2 ·Immunology

Bonebridge

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Klox Biophotonic LumiHeal System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SIMPLEXA HSV 1&2 DIRECT

FDA 510(k)

FDA Class 2 ·Microbiology

Acclarent Aera Eustachian Tube Balloon Dilation System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

FDA 510(k)

FDA Class 2 ·Microbiology

VerTouch Spinal Imaging Device

FDA 510(k)

FDA Class 2 ·Anesthesiology

RefleXion Medical Radiotherapy System (RMRS)

FDA 510(k)

FDA Class 2 ·Radiology

EyeBOX

FDA 510(k)

FDA Class 2 ·Neurology

WOUNDCHEK Bacterial Status

FDA 510(k)

FDA Class 2 ·Microbiology

TrueTear Intranasal Tear Neurostimulator

FDA 510(k)

FDA Class 2 ·Ophthalmic

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator

FDA 510(k)

FDA Class 2 ·Microbiology

Neoasis

FDA 510(k)

FDA Class 2 ·General Hospital

Zuno Smart Sterilization Container

FDA 510(k)

FDA Class 2 ·General Hospital

POMC/PCSK1/LEPR CDx Panel

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Oxiplex®

FDA 510(k)

FDA Class 2 ·Orthopedic