LIQUI SOL T4 RIA TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URODYNAMIC ANALYSIS MODULE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VENTRE/SEP T3 TEST SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LUMEN-4 URODYNAMIC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology

FDA 510(k)

FDA Class 2 ·Orthopedic

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology

FDA 510(k)

FDA Class 2 ·Orthopedic

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology

FDA 510(k)

FDA Class 2 ·Orthopedic

Radioimmunoassay, Total Triiodothyronine

FDA classification

FDA Class 2 ·Radioimmunoassay, Total Triiodothyronine

Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

FDA classification

FDA Class 2 ·Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System

FDA 510(k)

FDA Class 2 ·Orthopedic

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Human Lyophilized Dura Mater

FDA classification

FDA Class 2 ·Human Lyophilized Dura Mater

Immunoglobulin G (Igg) Infusion System

FDA classification

FDA Class 2 ·Immunoglobulin G (Igg) Infusion System

Infusion Pump, Drug Specific, Pharmacy-Filled

FDA classification

FDA Class 2 ·Infusion Pump, Drug Specific, Pharmacy-Filled

Digital Pathology Display

FDA classification

FDA Class 2 ·Digital Pathology Display

System, Suction, Lipoplasty

FDA classification

FDA Class 2 ·System, Suction, Lipoplasty

Test, Methadone, Employment And Insurance Testing, Exempt

FDA classification

FDA Class 2 ·Test, Methadone, Employment And Insurance Testing, Exempt

Whole Exome Sequencing Constituent Device

FDA classification

FDA Class 2 ·Whole Exome Sequencing Constituent Device