DAILY ACTIVITY ASSIST DEVICE (MOBILE STANDING AID)

FDA 510(k)

FDA Class 2 ·Physical Medicine

PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)

FDA 510(k)

FDA Class 2 ·Ophthalmic

ANGIO-PRESS LITE DVT Compression Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANGIO-PRESS DVT Compression Device Model Name: IPCS

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

INSERTION GAIN OPTIMIZER IGO-1000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TANDEMHEART FEMORAL VENOUS CANNULA SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN(R) HYDROCARE(R) CLEAN & DISINFECT SOLUTIO

IP SPECIFIC E

FDA 510(k)

FDA Class 2 ·Immunology

IGE EIA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOGLOBULIN E TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

SURGEON'S GLOVES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

METAL URETERAL BASKET STONE DISLODGER, HELICAL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology