PRESTIGE AMERITECH FACE MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA

FDA 510(k)

FDA Class 2 ·General Hospital

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600

FDA 510(k)

FDA Class 2 ·Immunology

AXIS 5.5 Lumbar Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Axis Chena Cervical PEEK Spacer System

FDA 510(k)

FDA Class 2 ·Orthopedic

Axis Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

C2000 AUTOMATED MANIFOLD KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAS (COMPUTERIZED ANALYZER SYSTEM)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST PLUS 4 ANGIOGRAPHIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST GENTOO CONTRAST INJECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAAS MRV VERSION 3.0

FDA 510(k)

FDA Class 2 ·Radiology

ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO ACIST CL 100H

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST 4 FRENCH ANGIOGRAPHIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

SmartClip Secure Soft Tissue Marker

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BICART

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology