10,000 results · 58ms · Sources: EU EUDAMED, US FDA

Tinto p14 ARF, RMab

FDA UDI
BIO SB, INC.·B502BSB35960·P14 ARF is a rabbit monoclonal antibody derived...

Estrogen Receptor MMab

FDA UDI
BIO SB, INC.·L502BSB2744·Estrogen receptor clone BSB-1 is a mouse monocl...

Cytokeratin 8 & 18 MMab

FDA UDI
BIO SB, INC.·L502BSB5417·Anti-Cytokeratin 8 & 18 is a cocktail of mouse ...

Tinto Ksp-Cadherin MMab

FDA UDI
BIO SB, INC.·B502BSB62830·Ksp-Cadherin is a mouse monoclonal antibody der...

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval
FDA Class 3 ·HER2 FISH PHARMADX KIT

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

FDA Pre-Market Approval
FDA Class 3 ·oncoRevealTM CDx

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·GFX 2 OVER-THE-WIRE CORONARY STSENT SYSTEM

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LifePulse High Frequency Ventilator

LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

RapidSorb

FDA UDI
Synthes GmbH·10887587057279·RAPIDSORB IPS STERILITY SHIELD

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AXSYM ANTI-HCV

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROPACE RNS SYSTEM

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MEMORYGEL BREAST IMPLANT

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·LIFESTENT VASCULAR STENT SYSTEMS

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·COLOGUARD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC AT500 DDDRP PACING SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·COFLEX INTERLAMINAR TECHNOLOGY