345 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
×
POLYBONE
FDA 510(k)
FDA Class 2
·Neurology
ALBUMIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
M-46 GOLD BASE DENTAL ALLOY
FDA 510(k)
FDA Class 2
·Dental
ATLAS IMPLANT SYSTEM- MINI PLUS
FDA 510(k)
FDA Class 2
·Dental
BioCode Gastrointestinal Pathogen Panel (GPP)
FDA 510(k)
FDA Class 2
·Microbiology
T-4 RIASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TOTAL BILIRUBIN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE
FDA 510(k)
FDA Class 2
·Ophthalmic
AST/SGOT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MYALLERGYTEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DONG BANG ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
C-76 GOLD BASE DENTAL ALLOY
FDA 510(k)
FDA Class 2
·Dental
POLYBONE GRANULE & BLOCK
FDA 510(k)
FDA Class 2
·Orthopedic
TOTAL PROTEIN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
T-3 UPTAKE/RIASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
FDA 510(k)
FDA Class 2
·Neurology
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·AMPLICOR HEPATITIS C VIRUS (HCV) TEST
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·FLEXTOME CUTTING BALLOON