ARK™ Lacosamide Assay; ARK™ Lacosamide Calibrator; ARK™ Lacosamide Control

FDA registration

ARK DIAGNOSTICS INC·1 product·🇺🇸 United States

ARK Lacosamide Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Immunoassay, Anti-Seizure Drug

FDA classification

FDA Class 2 ·Immunoassay, Anti-Seizure Drug

Nellcor Oximax Sensors

FDA registration

Sterigenics US LLC·1 product·🇺🇸 United States

Nellcor Oximax Sensors

FDA registration

Sterigenics U.S., LLC·1 product·🇺🇸 United States

micro-albumin in urine, EasyRA assay

FDA registration

MEDICA CORP.·2 products·🇺🇸 United States

LEFT HEART SUMP - 90 DEGREE

FDA UDI

NOVOSCI CORP.·B0662010890000·A hand-held device designed to regulate and dir...

Genius AI Detection

FDA registration

HOLOGIC, INC.·1 product·🇺🇸 United States

FINDER G6PD Test System, Baebies, Finder

FDA registration

BAEBIES INC.·1 product·🇺🇸 United States

OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

POLYMACON

FDA 510(k)

FDA Class 2 ·Ophthalmic

Lenses, Soft Contact, Daily Wear

FDA classification

FDA Class 2 ·Lenses, Soft Contact, Daily Wear

Oximeter

FDA classification

FDA Class 2 ·Oximeter