10,000 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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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
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 Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact
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
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR UP TO 30 NIGHTS CONTINUOUS WEAR
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN); Rhythmia HDx Ablation Connection Box (Maestro);RHYTHMIA HDx
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
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
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
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