LEDEX WL070+

FDA 510(k)

FDA Class 2 ·Dental

Swaive Thermometer SWT1A

FDA 510(k)

FDA Class 2 ·General Hospital

MTS Imipenem-relebactam 0.002/4-32/4 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

RENAX A.V. FISTULA NEEDLE SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment

FDA 510(k)

FDA Class 2 ·Dental

Anker Dental Implant System - SB-III, ST and AT series

FDA 510(k)

FDA Class 2 ·Dental

ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOTEQ Drainage Catheter BT-PDS-series

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set

FDA 510(k)

FDA Class 2 ·Cardiovascular

INDEX BPM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear

FDA 510(k)

FDA Class 2 ·Ophthalmic

Si-Hy (olifilcon B) color silicone hydrogel soft contact lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

SENTINEL PLASMAPROTEINS CAL 3X

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Everyway Facial MENS

FDA 510(k)

FDA Class 2 ·Neurology

WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A

FDA 510(k)

FDA Class 2 ·Physical Medicine

MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LAITEST Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PIEZOSURGERY PLUS

FDA 510(k)

FDA Class 2 ·Orthopedic

Physica LMC Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

SMR Reverse Liner

FDA 510(k)

FDA Class 2 ·Orthopedic