584 results
·
99ms
·
Sources: EU EUDAMED, US FDA
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)
Agent, Absorbable Hemostatic, Non-Collagen Based
FDA Pre-Market Approval
FDA Class 3
·SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT
Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape
FDA 510(k)
FDA Class 2
·General Hospital
BREG
FDA UDI
BREG, INC.·00672736020678·
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·LeukoStrat CDx FLT3 Mutation Assay
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·CAPSURE SP & CAPSURE Z
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·SUREFIX
Lipoprotein, Low Density, Removal
FDA Pre-Market Approval
FDA Class 3
·B.BRAUN,S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P) SYSTEM
Immunohistochemistry Assay, Antibody, Ki-67
FDA Pre-Market Approval
FDA Class 3
·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
Immunohistochemistry Assay, Antibody, Ki-67
FDA Pre-Market Approval
FDA Class 3
·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
FDA Pre-Market Approval
FDA Class 3
·MiSight 1 Day (omafilcon A)
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·FLEXTIP PLUS INTRASPINAL CATHETER KIT
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·RELIANCE FAMILY OF LEADS
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BIOFINITY XR TORIC
Innova Vision Inc. Fab 1
FDA registration
Innova Vision Inc. Fab 1·2 products·🇹🇼 Taiwan
Innova Vision Inc. Fab 1
FDA registration
Innova Vision Inc. Fab 1·1 product·🇹🇼 Taiwan
Innova Vision Inc. Fab 1
FDA registration
Innova Vision Inc. Fab 1·2 products·🇹🇼 Taiwan
Innova Vision Inc. Fab 1
FDA registration
Innova Vision Inc. Fab 1·2 products·🇹🇼 Taiwan