Cardiopulmonary Bypass Catheter Kit

FDA classification

FDA Class 2 ·Cardiopulmonary Bypass Catheter Kit

Force Fiber OrthoTape suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

cobas® liat CT/NG nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

MAXReach Laser Probe

FDA 510(k)

FDA Class 2 ·Ophthalmic

cobas® liat CT/NG/MG nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 v2 nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPEDE-FX Embolization Plug

FDA 510(k)

FDA Class 2 ·Cardiovascular

QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)

FDA 510(k)

FDA Class 2 ·Hematology

BAYER IMMUNO 1 HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Her-2, ER, PR IHControls

FDA 510(k)

FDA Class 2 ·Hematology

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)

FDA 510(k)

FDA Class 2 ·Immunology

BAYER ADVIA CENTAUR HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

CAPENERGY - C100, C200, C300, C400, C50

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX

MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM

FDA 510(k)

FDA Class 2 ·Radiology

REDI-DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery