OMNILUX REVIVE AND OMNILUX PLUS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOUNDATION HYBRID COMPOSITE

FDA 510(k)

FDA Class 2 ·Dental

GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRACELL SUCTION SPONGE

FDA 510(k)

FDA Class 2 ·Ophthalmic

VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Daylily Single Use Sterile Embryo Transfer Catheter

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Radial Compression Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8

FDA 510(k)

FDA Class 2 ·Radiology

Patient Monitoring Cable (SpO2 Extension Cable)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MAGLUMI 2000 FT4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MAGLUMI 2000 25-OH Vitamin D

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)

FDA 510(k)

FDA Class 2 ·Dental

CARPEDIEM System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMS100 Tri-Wave Combination Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine