PFZ PORCELAIN SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY)

FDA 510(k)

FDA Class 2 ·Immunology

ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY)

FDA 510(k)

FDA Class 2 ·Immunology

ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY)

FDA 510(k)

FDA Class 2 ·Immunology

GRAVITY PLUS CONTROLLER/COMPOUNDER

FDA 510(k)

FDA Class 2 ·General Hospital

SnapshotNIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vario-Cup System

FDA 510(k)

FDA Class 2 ·Orthopedic

iLet® Dosing Decision Software

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

InVision™ 1.5 Surgical Theatre

FDA 510(k)

FDA Class 2 ·Radiology

EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS

FDA 510(k)

FDA Class 2 ·Orthopedic

Exactech Alteon Modular Dual Mobility (MDM) System

FDA 510(k)

FDA Class 2 ·Orthopedic

iLet® ACE Pump

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Direxion and Direxion HI-FLO Torqueable Microcatheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

HUMID-VENT HEPA

FDA 510(k)

FDA Class 2 ·Anesthesiology

Uroject12 Syringe Lever

FDA 510(k)

FDA Class 2 ·General Hospital

CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1

FDA 510(k)

FDA Class 2 ·Neurology

HYBRID ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery