10,000 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·BreathTek UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Pearl Vision Monthly (confilcon A) Soft (Hydriohilic) Contact Lenses , Pearle Vision Monthly for Astigmatism (comfilcon
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear, Euclid Orthokeratology (tisilfocon A) Contact Le
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·FINELINE II Sterox Leads, Suture Sleeve Accessory for FINELINE II Leads, (Pacing Leads and Accessories)
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·CROSS FLEX LC BALLOON-EXPANDABLE STENT WITH OVER THE WIRE DELIVERY SYSTEM FOR CORONARY ARTERIES
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor
Stent, Iliac
FDA Pre-Market Approval
FDA Class 3
·S.M.A.R.T. NITINOL STENT SYSTEM & S.M.A.R.T. CONTROL NITINOL STENT SYSTEM FOR USE IN LLIAC ARTERIES
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·FINELINE II STEROX & FINELINE II STEROX EZ, SUTURE SLEEVE ACCESSORY(FOR FINELINE II LEADS)
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THINPEP 2000 SYSTEM AND THINPREP 3000 PROCESSOR: PRESERVCYT SOLUTION, ALTERNATIVE TRANSPORT MEDIUM FOR ROCHE DIAGNOSTIC
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VENTAK(R) PRX(R) AICD(TM) SYSTEM FOR PECTORAL REPLACEMENT OF VENTAK PRXIII PULE GENERATOR
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Biofinity (comfilcon A) XR Toric and Toric Multifocal Soft (Hydrophilic) Contact Lenses for Extended Wear
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended wear