DAILY ACTIVITY ASSIST DEVICE (MOBILE STANDING AID)

FDA 510(k)

FDA Class 2 ·Physical Medicine

LGO-Surgical Laser Fibers

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INSERTION GAIN OPTIMIZER IGO-1000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MEDX REUSABLE SHARPS CONTAINER

FDA 510(k)

FDA Class 2 ·General Hospital

MX4000

FDA 510(k)

FDA Class 2 ·General Hospital

MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator

FDA 510(k)

FDA Class 2 ·Anesthesiology

PEACH 2, PEACH 2 Duo, PEACH 2 go

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius System 100 and GI Genius System 200

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·artus CMV RGQ MDx Kit and artus CMV QS-RGO MDx Kit

SONON Ultrasound Imaging System, Model: 300L

FDA 510(k)

FDA Class 2 ·Radiology

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Hearing Aid Feature (HAF)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite

FDA 510(k)

FDA Class 2 ·Dental

BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

IP SPECIFIC E

FDA 510(k)

FDA Class 2 ·Immunology