2,751 results · 43ms · Sources: EU EUDAMED, US FDA

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Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD AND VIRTUOSO II DR VR ICD

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·Bond™ Oracle™ HER2 IHC System

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 22C3 PHARMDX

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·BOND ORACLE HER2 IHC SYSTEM

Estrogen Receptor, Ready to use IHC (Quanto)

FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693559096·

Pad FHC Head Section Pad (Pressure Relief)

FDA UDI
FUTURE HEALTH CONCEPTS, INC.·B337BBFHC1000H1·Fhc Head Section Pad (Pressure Relief). This P...

Estrogen Receptor, Ready to use IHC (UVLP)

FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693180313·

FHC 1000 Radiographic Top O.R. Table(220V)

FDA UDI
FUTURE HEALTH CONCEPTS, INC.·B337FHC1000220V1·Remote Control Operating Room Table With Radiog...

Progesterone Receptor Ready to use IHC (UVLP)

FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693180337·

Progesterone Receptor Ready to use IHC (Quanto)

FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693559577·

intelliPATH Folate Receptor alpha IHC Assay Kit

FDA UDI
BIOCARE MEDICAL LLC·00847627008985·

SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

FDA registration
TECO DIAGNOSTICS·3 products·🇺🇸 United States

COMPANHIA BRASILEIRA DE ESTERILIZACAO

FDA registration
COMPANHIA BRASILEIRA DE ESTERILIZACAO·3 products·🇧🇷 Brazil

Vacuette Blood Collection Tubes 4NC ESR sodium citrate 3.2%

FDA registration
MEDISCAN GMBH & CO. KG·3 products·🇦🇹 Austria

Corgenix Anti-Beta-2 Glycoprotein IgA Semi-Quantitative Test Kit

FDA registration
CORGENIX, INC.·3 products·🇺🇸 United States

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval
FDA Class 3 ·Ki-67 IHC pharmDx

SLE ANTI-N-DNA LATEX TEST

FDA 510(k)
FDA Class 2 ·Immunology

HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE

FDA 510(k)
FDA Class 2 ·Immunology

ANA LATEX SLIDE TEST

FDA 510(k)
FDA Class 2 ·Immunology

ELIAS DSDNA ABS

FDA 510(k)
FDA Class 2 ·Immunology