Aequalis Reversed Shoulder Prosthesis

FDA registration

APS MATERIALS INC. IRELAND·2 products·🇮🇪 Ireland

APS MATERIALS INC. IRELAND

FDA registration

APS MATERIALS INC. IRELAND·1 product·🇮🇪 Ireland

Konan CellChek D CD-15

Device

EU IVDR · Eu Ivd Class A ·Konan Medical, Inc.·On the market·20 countries

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV Reagent Kit, Alinity i Anti-HCV Reagent Kit

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE Reagent Kit, Alinity i Anti-HBc Reagent Kit

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AFP Reagents, Alinity i AFP Reagent Kit

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT Total PSA Reagent Kit, Alinity i Total PSA Reagent Kit

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB Reagent, ARCHITECT AUSAB Reagent Kit, Alinity i Anti-HBs Reagent Kit

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT Free PSA Reagent Kit, Alinity i Free PSA Reagent Kit

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAg Qualitative Reagent, ARCHITECT HBsAg Qualitative Confirmatory Reagent, Alinity i HBsAg Qualitative II Re

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CHORUS DDD PACEMAKER

HemoBand HB-NSXL

FDA registration

INNOVATIONS FOR ACCESS, INC.·1 product·🇺🇸 United States

HemoBand HB-1M

FDA registration

INNOVATIONS FOR ACCESS, INC.·1 product·🇺🇸 United States

Myoaligner Appliance

FDA 510(k)

FDA Unclassified ·Unknown

BRYAN SPINAL FIXATER (BSF)

FDA 510(k)

FDA Class 2 ·Orthopedic

USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Fresco Dynamic Dentine D2 D (10 g)

FDA UDI

ZIRKONZAHN SRL·D800KEAD72310·Content: 10 g

Fresco Dynamic Dentine D2 D (20 g)

FDA UDI

ZIRKONZAHN SRL·D800KEAD7232·Content: 20 g

Fresco Dynamic Dentine D2 D (10 g)

FDA UDI

ZIRKONZAHN SRL·D800KEAD7231·Content: 10 g