Medical Protective Masks

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0

FDA 510(k)

FDA Class 2 ·Radiology

Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Surgical face mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Adena-Zina Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Adena-Zina System

FDA 510(k)

FDA Class 2 ·Orthopedic

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