ETUDE (MODEL NUMBERS 24A05 & 24A06)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URODYNAMIC MEASURING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

LABORIE URODYNAMICS PROCESSOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BROWNE MODEL UD-4

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THE DENVER SPLINT

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

UROLAB JANUS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL 4-SC FOUR WAY STOPCOCK

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMERICAN NASAL SPONGE

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

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

LUMEN-4 URODYNAMIC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System; FreeStyle Libre 14 Day Flash Glucose Monitoring System

5164, 5272, 5260

FDA registration

R & D BATTERIES, INC.·3 products·🇺🇸 United States

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Prospera SCS System, Resilience Surgical Lead, Embrace One

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM