ASAHI TORNUS SUPPORT CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SUPERCATH V

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Medical Non-Ablative Fractional Laser Systems

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AFF (MARK I) VOLUMETRIC INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAGSTIM DOUBLE 70-2 COIL

FDA 510(k)

FDA Class 2 ·Neurology

GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Sensilight Pro / Pistol IPL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tandry Compression Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES

FDA 510(k)

FDA Class 2 ·Microbiology

AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

5D Viewer

FDA 510(k)

FDA Class 2 ·Radiology

ADAPTABLE CLASS III MASK

FDA 510(k)

FDA Class 2 ·Dental

INSTRUMENT CASSETTE (EFCCL1-F)

FDA 510(k)

FDA Class 2 ·General Hospital

MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments

FDA 510(k)

FDA Class 2 ·Dental

Pinehurst Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

LVivo Software Application

FDA 510(k)

FDA Class 2 ·Radiology

HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)

FDA 510(k)

FDA Class 2 ·Cardiovascular