Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRxcell CoCr Coronary Stent on RX System

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY ON ELECSYS 2010

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV ON COBAS E 601

OTN Implants B.V.

Authorized representative

🇳🇱 Netherlands

Procalcitonin (PCT) Calibrators

FDA UDI

STANBIO LABORATORY, L.P.·00657498001967·The Stanbio Procalcitonin (PCT) Calibrator Set ...

Access PCT

FDA UDI

IMMUNOTECH·15099590719531·The Access PCT assay is a paramagnetic, chemilu...

Procalcitonin (PCT) Bi-Level Controls

FDA UDI

STANBIO LABORATORY, L.P.·00657498001974·The Stanbio Procalcitonin (PCT) Control Set is ...

Access PCT

FDA UDI

Beckman Coulter, Inc.·15099590736002·The Access PCT assay is a paramagnetic, chemilu...

Procalcitonin LiquiColor

FDA UDI

STANBIO LABORATORY, L.P.·00657498001950·Stanbio Procalcitonin (PCT) LiquiColor® is inte...

BIOLOK SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

BILOK ST SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

ULTRA-VIOLET GOGGLETS

FDA 510(k)

BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

FORTOSS-CEMA

FDA 510(k)

FDA Class 2 ·Dental

Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIOLOK SCREW, BIOSTEON SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

RIGI-FIX HIP STEM SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOSTEON CROSS PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

Irrigation Tubing with CO2 or Air

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIFOTI USB 2.0 SYSTEM

FDA 510(k)

FDA Class 2 ·Dental