1,516 results · 38ms · Sources: EU EUDAMED, US FDA

Tortoise Turning and Positioning System

FDA registration
Molnlycke Manufacturing US, LLC·1 product·🇺🇸 United States

BinaxNOW Streptococcus pneumoniae Test

FDA registration
Abbott Diagnostics Scarborough, Inc.·1 product·🇺🇸 United States

BinaxNow Strep A Test

FDA registration
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·1 product·🇺🇸 United States

Legionella Urinary Antigen Enzyme Immunoassay Kit

FDA registration
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·1 product·🇺🇸 United States

Validate CM2 product code 402ab

FDA registration
LGC Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

Multiple

FDA registration
ACME-MONACO CORP.·1 product·🇺🇸 United States

Lipoprotein 1 Calibration Verification Test Set

FDA registration
LGC Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

VALIDATE GC3 Calibration Verification / Linearity Test Kit

FDA registration
LGC Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

MSE-12

Basic UDI-DI
EU MDD · Eu Md Class 2a ·BioMaterials Korea, Inc.·1 device

MSE-10

Basic UDI-DI
EU MDD · Eu Md Class 2a ·BioMaterials Korea, Inc.·1 device

MSE-8

Basic UDI-DI
EU MDD · Eu Md Class 2a ·BioMaterials Korea, Inc.·1 device

MSE-6

Basic UDI-DI
EU MDD · Eu Md Class 2a ·BioMaterials Korea, Inc.·1 device

mse-11

Basic UDI-DI
EU MDD · Eu Md Class 2a ·BioMaterials Korea, Inc.·1 device

mjn-SERAS

Basic UDI-DI
EU MDD · Eu Md Class 2a ·MJN Neuroserveis S.L.·1 device

FEMNA Care

Basic UDI-DI
EU MDR · Eu Md Class 1 ·FEMNA Health M.E. GmbH·1 device

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters

PARAMAX ALKALINE PHOSPHATASE REAGENT-

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ALP REAGENT SET, ALKALINE PHOSPHATASE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GILCHEM ALP REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU.

FDA 510(k)
FDA Class 2 ·Clinical Chemistry