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