BI-FLEX URETERAL ACCESS SHEATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOFLOW II - Irrigation, Warming and Suction System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RocaJJ Soft Stents

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ROCAMED ROCAUS PLATINUM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RocaTub Ureteral Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bi-Flex Evo

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CAMCERAM TCP

FDA 510(k)

FDA Class 2 ·Orthopedic

SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030

FDA 510(k)

FDA Class 2 ·Orthopedic

Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants

FDA 510(k)

FDA Class 2 ·Orthopedic

OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,

FDA 510(k)

FDA Class 2 ·Orthopedic

ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM

FDA 510(k)

FDA Class 2 ·Hematology

Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

FDA classification

FDA Class 2 ·Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Analyzer, Gas, Oxygen, Gaseous-Phase

FDA classification

FDA Class 2 ·Analyzer, Gas, Oxygen, Gaseous-Phase

Bcr/Abl1 Monitoring Test

FDA classification

FDA Class 2 ·Bcr/Abl1 Monitoring Test