4,878 results · 46ms · Sources: EU EUDAMED, US FDA

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GC Orthodontics America Inc.

FDA registration
GC Orthodontics America Inc.·1 product·🇺🇸 United States

GC Ortho

FDA registration
GC Orthodontics America Inc.·1 product·🇺🇸 United States

GC Orthodontics America Inc.

FDA registration
GC Orthodontics America Inc.·1 product·🇺🇸 United States

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT AUSAB, Alinity i Anti-HBs

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Oncomine Dx Target Test

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT HBsAg Qualitative/Confirmatory, Alinity i HBsAg Qualitative II/Confirmatory

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval
FDA Class 3 ·SPECTRANTICS SLS II LASER SHEATH

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Praxis Extended RAS Panel

DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL

FDA 510(k)
FDA Class 2 ·Immunology

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV Test

Personal Kinetigraph (PKG) System Gen 2 Plus

FDA 510(k)
FDA Class 2 ·Neurology

PERSONAL KINETIGRAPH (PKG) SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

Personal Kinetigraph (PKG) System

FDA 510(k)
FDA Class 2 ·Neurology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·RAPTORAIL PTCA DILATATION CATHETER (RX)

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·Oxford Partial Knee System

D466696 Radiation therapy marking device

FDA registration
PROMOLDING BV·1 product·🇳🇱 Netherlands

NICOTINE PLUS LEVEL 2

FDA UDI
UTAK LABORATORIES, INC.·B800NICO2FQCLC0·NICOTINE PLUS LEVEL 2

DRUGS OF ABUSE SCREEN POSITIVE

FDA UDI
UTAK LABORATORIES, INC.·B800DAUPOSFQCVU0·DRUGS OF ABUSE SCREEN POSITIVE

DRUGS OF ABUSE SCREEN NEGATIVE

FDA UDI
UTAK LABORATORIES, INC.·B800DAUNEGFQCVU0·DRUGS OF ABUSE SCREEN NEGATIVE