Alpha-1-Fetoprotein (AFP) - RP001, PDR013

FDA registration

DIAGNOSTIC BIOSYSTEMS·1 product·🇺🇸 United States

Non sterile: Adult Diaper

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Samela, Inc. d/b/a NorthShore Care Supply·1 device

Catheter, Nasal, Oxygen

FDA classification

FDA Class 1 ·Catheter, Nasal, Oxygen

Haptoglobin, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Haptoglobin, Fitc, Antigen, Antiserum, Control

CardioChek Plus Test System, CardioChek Home Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PROTURA COUCH SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

TrueCare Biomedix Tamper Evident Cap

FDA 510(k)

FDA Class 2 ·General Hospital

AnatomicAligner

FDA 510(k)

FDA Class 2 ·Radiology

EnsoETM

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnsoETM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Boston Keratoprosthesis, Type I Lucia

FDA 510(k)

FDA Class 2 ·Ophthalmic

PTS Professional Chemistry Kit

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PROTURA COUCH SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

BostonSight® Specialty Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE)

FDA 510(k)

FDA Class 1 ·Dental

CardioChek Plus Test System; CardioChek Plus Home Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ensoETM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline™ Flex Embolization Device (Pipeline™ Flex); Pipeline™ Flex Embolization Device with Shield Technology™ (Pipelin

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·PIPLINE TM EMBOLIZATION DEVICE

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline Flex Embolization Device