IDS-ISYS INTACT PTH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OSTEOBOOST-BMA

FDA 510(k)

FDA Class 2 ·General Hospital

GRAFTLOCK SCREW, ST SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

SIGMA ELITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit

FDA 510(k)

FDA Class 2 ·Immunology

OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

STAR Apollo Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SMART TENS, MODEL: D-BC05T

FDA 510(k)

FDA Class 2 ·Neurology

OptosAdvance 4.0 Software

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED CAPTIA(R) SYPHILIS-M

FDA 510(k)

FDA Class 2 ·Microbiology

KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454

FDA 510(k)

FDA Class 2 ·Anesthesiology

OPTYSE OPHTHALMOSCOPE

FDA 510(k)

FDA Class 2 ·Ophthalmic

HAWK ANAESTHESIA INDUCTION UNIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation

FDA 510(k)

FDA Class 2 ·Neurology

1,25-DIHYDROXY VITAMIN D EIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology