LAMINOPLASTY FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

InferRead Lung CT.AI

FDA 510(k)

FDA Class 2 ·Radiology

NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

InferRead CT Stroke.AI

FDA 510(k)

FDA Class 2 ·Radiology

NUVASIVE LATERAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Adena-Zina System

FDA 510(k)

FDA Class 2 ·Orthopedic

Ureterorenoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Diode laser hair removal machine (QDTM-02)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single-use Sterile High-pressure Angiographic Syringes and Accessories

FDA 510(k)

FDA Class 2 ·Cardiovascular

Patient Monitoring Cable (SpO2 Extension Cable)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS

LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URODYNAMIC ANALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACUMASTER BRAND ACUPUNCTURE NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

MASC Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TD-7301 Spirometer (TD-7301)

FDA 510(k)

FDA Class 2 ·Anesthesiology

MetaLite DX Digital Pathology Software

FDA 510(k)

FDA Class 2 ·Pathology