Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac

FDA 510(k)

FDA Class 2 ·Cardiovascular

MultiGen™ 2 RF Generator System

FDA 510(k)

FDA Class 2 ·Neurology

OsteoCool V-2 RF Ablation System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OsteoCool V-3 RF Ablation System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OsteoCool V-3 RF Ablation System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SUN TANNING BED MODEL EC-3RF

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AUTO-VAC BIOPSY NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARPAL ENGAGING WRIST FUSION PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Immunology

INVIRO SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

BAUMER CEMENTED HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

BAUMER FEMORAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

BAUMER LOCKING NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

BAUMER MULLER HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

SCARLET AC-T

FDA 510(k)

FDA Class 2 ·Orthopedic

PERLA® TL posterior osteosynthesis system

FDA 510(k)

FDA Class 2 ·Orthopedic

TRYPTIK2 C-Plate Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

SPINEART Navigation Instrument System

FDA 510(k)

FDA Class 2 ·Neurology

PERLA TL Posterior Osteosynthesis System

FDA 510(k)

FDA Class 2 ·Orthopedic

Scarlet® AL-T

FDA 510(k)

FDA Class 2 ·Orthopedic