ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257

FDA 510(k)

FDA Class 2 ·Immunology

Orthopantomograph™ OP 3D LX

FDA 510(k)

FDA Class 2 ·Radiology

DIGORA OPTIME (OR DIGORA ONTIME)

FDA 510(k)

FDA Class 2 ·Dental

BonAlive Granules

FDA 510(k)

FDA Class 2 ·Orthopedic

HAAG-STREIT FUNDUS MODULE 300

FDA 510(k)

FDA Class 2 ·Ophthalmic

AS/3 PRESSURE TEMPERATURE MODULE, M-PT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nexstim Navigated Brain Therapy (NBT) System 2

FDA 510(k)

FDA Class 2 ·Neurology

Radioimmunoassay, Angiotensin I And Renin

FDA classification

FDA Class 2 ·Radioimmunoassay, Angiotensin I And Renin

Self-Fitting Air-Conduction Hearing Aid, Prescription

FDA classification

FDA Class 2 ·Self-Fitting Air-Conduction Hearing Aid, Prescription

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Instruments Designed For Press-Fit Osteochondral Implants

FDA classification

FDA Class 2 ·Instruments Designed For Press-Fit Osteochondral Implants

Self-Fitting Air-Conduction Hearing Aid, Over The Counter

FDA classification

FDA Class 2 ·Self-Fitting Air-Conduction Hearing Aid, Over The Counter

Screw Sleeve Bone Fixation Device

FDA classification

FDA Class 2 ·Screw Sleeve Bone Fixation Device

Screw Sleeve Bone Fixation Device, Spine

FDA classification

FDA Class 2 ·Screw Sleeve Bone Fixation Device, Spine

Ventilator, Continuous, Minimal Ventilatory Support, Home Use

FDA classification

FDA Class 2 ·Ventilator, Continuous, Minimal Ventilatory Support, Home Use

Implant, Endosseous, Orthodontic

FDA classification

FDA Class 2 ·Implant, Endosseous, Orthodontic

Prosthesis, Rib Replacement

FDA classification

FDA Class 2 ·Prosthesis, Rib Replacement

Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

FDA classification

FDA Class 2 ·Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

Digital Pathology Image Viewing And Management Software

FDA classification

FDA Class 2 ·Digital Pathology Image Viewing And Management Software

Control Material, Blood Circulating Epithelial Cancer Cell

FDA classification

FDA Class 2 ·Control Material, Blood Circulating Epithelial Cancer Cell