PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Microwave Ablation Antennas

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OMNILUX REVIVE AND OMNILUX PLUS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA

FDA 510(k)

FDA Class 2 ·Hematology

NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY

FDA 510(k)

FDA Class 2 ·Dental

ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK

FDA 510(k)

FDA Class 2 ·General Hospital