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