AURECAST SUPER INLAY

FDA 510(k)

FDA Class 2 ·Dental

LASEREX INTEGRE, MODEL LP2532

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LEESPEC DISPOSABLE VAGINAL SPECULUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Osseointegrated Fixtures

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

M-COR HIP REPLACEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Signature Ceramic Femoral Head

FDA 510(k)

FDA Class 2 ·Orthopedic

STIMPOD NMS450 NERVE STIMULATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow

FDA 510(k)

FDA Class 2 ·Ophthalmic

Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo

FDA 510(k)

FDA Class 2 ·Ophthalmic

THE MARGRON HIP REPLACEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Precision AI Surgical Planning System (PAI-SPS)

FDA 510(k)

FDA Class 2 ·Orthopedic

SAMPLOK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Annalise Enterprise CXR Triage Trauma

FDA 510(k)

FDA Class 2 ·Radiology

World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC)

FDA 510(k)

FDA Class 2 ·Orthopedic

Genius Total Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo

FDA 510(k)

FDA Class 2 ·Ophthalmic

TI-TAMED SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BlueCheck™ Caries Detection & Monitoring

FDA 510(k)

FDA Class 2 ·Dental

PSK ENDOSCOPE CLEANING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)

FDA 510(k)

FDA Class 2 ·Ophthalmic