REP(R) IMMUNOFIX

FDA 510(k)

FDA Class 2 ·Immunology

LEESPEC DISPOSABLE VAGINAL SPECULUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SAMPLOK LUER KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

Notal Vision Home Optical Coherence Tomography (OCT) System

FDA 510(k)

FDA Class 2 ·Ophthalmic

PeekMed

FDA 510(k)

FDA Class 2 ·Radiology

PeekMed web

FDA 510(k)

FDA Class 2 ·Radiology

Delphos Implants Rigid Fixation System

FDA 510(k)

FDA Class 2 ·Dental

PeekMed web (v1)

FDA 510(k)

FDA Class 2 ·Radiology

AI4CMR v1.0

FDA 510(k)

FDA Class 2 ·Radiology

PeekMed web

FDA 510(k)

FDA Class 2 ·Radiology

Advanced Diffusion Analysis (ADA) application

FDA 510(k)

FDA Class 2 ·Radiology

Longitudinal Brain Imaging (LoBI) application

FDA 510(k)

FDA Class 2 ·Radiology

ALLURA XPER FD10

FDA 510(k)

FDA Class 2 ·Radiology

ULTRASONIC PACHYMETER

FDA 510(k)

FDA Class 2 ·Radiology

Multi-Modality Tumor Tracking (MMTT) application

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION ACATHETER WITH HYDRO/PEL COATING AND ANTI BACK BLEED DEVICE

NOBLUS DIAGNOSTIC ULTRASOUND SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37

FDA 510(k)

FDA Class 2 ·Radiology