INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5

FDA 510(k)

FDA Class 2 ·Hematology

Atellica® IM High-Sensitivity Troponin I (TnIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC

FDA 510(k)

FDA Class 2 ·Immunology

Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GentleCath Glide Intermittent Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Avant HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Entrant HF CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T; Gallant HF C

Axilum Robotics TMS-Cobot adaptation kit for Magstim Air Film Coil (AFC) coil

Device

EU MDR · Eu Md Class 2a ·Axilum Robotics·On the market·32 countries

Axilum Robotics TMS-Cobot adaptation kit for Magstim Air Film Coil (AFC) coil

Device

EU MDR · Eu Md Class 2a ·Axilum Robotics·On the market·32 countries

LPA400C Lipoprotein (a) Calibrator

FDA registration

HORIBA INSTRUMENTS INCORPORATED·3 products·🇺🇸 United States

Alinity c Lp(a) Reagent Kit

FDA registration

BIOKIT S.A.·3 products·🇪🇸 Spain

H7575-CTL, Pointe Homocysteine Controls

FDA registration

HORIBA INSTRUMENTS INCORPORATED·3 products·🇺🇸 United States

Carolina Liquid Chemistries Corp.

FDA registration

Carolina Liquid Chemistries Corp.·3 products·🇺🇸 United States

Caps Warmer

FDA registration

VOCO GMBH·3 products·🇩🇪 Germany

Calset Composite Warmer

FDA registration

ADDENT, INC.·3 products·🇺🇸 United States

AXIS SHIELD Homocysteine Control Kit (FHCY200/ B08177)

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·3 products·🇬🇧 United Kingdom

Quantia Lipoprotein(a) (LN 7K00-40, 7K00-41)

FDA registration

ABBOTT LABORATORIES·3 products·🇺🇸 United States