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

OMC ORTHOMET CANNULATED SCREW

FDA 510(k)

MultiGen™ 2 RF Generator System

FDA 510(k)

FDA Class 2 ·Neurology

PRE-DENT SYSTEM MODIFIED

FDA 510(k)

FDA Class 1 ·Hematology

PRE-DENT SYSTEM

FDA 510(k)

FDA Class 1 ·Hematology

PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE

FDA 510(k)

FDA Unclassified ·Unknown

PRE-DENT SYSTEM OR PRE-DENT II

FDA 510(k)

FDA Class 1 ·Hematology

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

SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

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

PATIENT EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

BAUMER CEMENTED HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

BAUMER FEMORAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic