ADVISOR, MODEL 9200

FDA 510(k)

FDA Class 2 ·Anesthesiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER

ACI PULSATING VACUUM PUMP SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYNTHES ACIS/VERTEBRAL SPACER CR

FDA 510(k)

FDA Class 2 ·Orthopedic

AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)

FDA 510(k)

FDA Class 2 ·Hematology

BCI-100 FECAL INCONTINENCE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

FDA 510(k)

FDA Class 2 ·Hematology

ACI SINGLE LUMEN BIOPSY NEEDLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BCI 3401 HANDHELD PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BICART

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMASATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Hysteroscope System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Vitrea View

FDA 510(k)

FDA Class 2 ·Radiology

MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL

FDA 510(k)

FDA Class 2 ·General Hospital

Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Clear Aligner

FDA 510(k)

FDA Class 2 ·Dental

DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GuideMia Ortho+

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology