Red Dot

FDA 510(k)

FDA Class 2 ·Radiology

700-123 EYE SHADE

FDA 510(k)

FDA Class 1 ·Ophthalmic

ORTHOTRON MUSCLE STIMULATOR MK II DC

FDA 510(k)

FDA Class 2 ·Physical Medicine

GRAFTSITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

STERILE STORM (R) OPERATING KIT

FDA 510(k)

FDA Class 2 ·Orthopedic

ANCHORMAN Tibial Ligament Fixation Device

FDA 510(k)

FDA Class 2 ·Orthopedic

STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT

FDA 510(k)

FDA Class 2 ·Orthopedic

STIMULAN -CALCIUM SULFATE BONE VOID FILTER

FDA 510(k)

FDA Class 2 ·Orthopedic

STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT

FDA 510(k)

FDA Class 2 ·Orthopedic

THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101

FDA 510(k)

FDA Class 2 ·Anesthesiology

OLYMPUS SUCTION PUMP, MODEL KV-5

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY STENT WITH HEPACOAT ON RAPTORAIL(RX)/RAPTOR(OTW) STENT DELIVERY SYSTEM

OX-ON A/S

Importer

🇩🇰 Denmark

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR XP CPSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping System

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR XP PSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE)

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE FOR USE ON THE DIMENSION VISTA 500 SYSTEM

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE FOR USE ON THE DIMENSION VISTA 500 SYSTEM