Sontro® OTC Hearing Aids (AI)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Eargo 5 , Eargo 6

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Intrisound™ Tuned Lumen® 155 Hearing Aids

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Concha Sol Hearing Aids (CL-1001)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

WSA Self-Fitting Hearing Aid Gen 2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Notal Vision Home Optical Coherence Tomography (OCT) System

FDA 510(k)

FDA Class 2 ·Ophthalmic

Nuheara IQbuds 2 PRO Hearing Aid

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·NDS LENS MAINTENANCE SYSTEM

SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISPOSABLE SURGICAL MASK (MODIFIED)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SELF-ADHESIVE ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Fat Reducing Low Level Laser

FDA classification

FDA Class 2 ·Fat Reducing Low Level Laser

WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA

FDA 510(k)

FDA Class 2 ·Anesthesiology

PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)

FDA 510(k)

FDA Class 2 ·Anesthesiology

SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology