COMPOSITE ALIGNER BUTTON

FDA 510(k)

FDA Class 2 ·Dental

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION

FDA 510(k)

FDA Class 2 ·Dental

MTA ROOT CANAL SEALER

FDA 510(k)

FDA Class 2 ·Dental

SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SELF-ADHESIVE RESIN CEMENT

FDA 510(k)

FDA Class 2 ·Dental

InnoSpire Go

FDA 510(k)

FDA Class 2 ·Anesthesiology

GYRUS ENDOUROLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GYRUS HYSTEROSCOPIC RESECTOSCOPE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PLASMAKINETIC ENDOUROLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PLASMAKINETIC GENERATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BABY DOPPLEX 4000 (BD4000)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GYRUS HYSTEROSCOPIC RESECTOSCOPE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FETAL ASSIST

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·MODEL 515 NEONATAL MONIOTR

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·R2L RAPID EXCHANGE BALLOON DILATATION CATHETER WITH EXTENDED PRESSURE RANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CAT

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·NDS LENS MAINTENANCE SYSTEM

Aneroid Type Blood Pressure Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular