Collection: FDA 510(k)
FDA 510K documents available for fast-track requests typically delivered within 1 to 2 weeks. Publicly Available documents delivered within 24 business hours.
Use Search below to find the 510k you are looking for by:
- Device Name
- Manufacturer
- Device Classification Name
- Regulation Number
- Classification Product Code
- Date Received
- Decision Date
- Regulation Medical Specialty
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FDA 510(k), K180220, SAGICO OSI Spinal System by Osimplant
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K202079, Physiq
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030861, HA PMI FLANGED ACETABULAR COMPONENT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040383, TRIFLANGE II ACETABULAR CUP SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K103720, SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K173274, Ceevra Reveal 2.0
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212896, Visible Patient Suite
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141654, THE BELMONT RAPID INFUSER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201808, X-Tack Endoscopic HeliX Tacking System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K203503, Camber Sacroiliac (SI) Fixation System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130649, SILK ROAD ACCESS CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143459, Silk Road Acccess Catheter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212525, Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132431, THERMAGE CPT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K894455, DECONTAMINATING KIT, SKIN: M291
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001409, GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220090, Visibly Digital Acuity Product
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200148, LightForce Orthodontic System (LFO System)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K211399, Sterile & Non-Sterile Level 3 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Isolation Gown
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K172284, NAPA LP-15 Airway Pressure Monitor
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K053597, I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093243, COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163406, Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121700, ULTHERA SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K180623, Ulthera System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K171111, Sculpsure
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160470, SculpSure
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150724, SculpSure
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150230, SculpSure
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162770, Relign System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K192155, Smith & Nephew DYONICS 25 Fluid Management System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K182882, CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K171237, FMS VUE II Fluid Management and Tissue Debridement System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200160, 740 SafeSAT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K191259, Stryker CrossFlow Integrated Arthroscopy Pump
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K211496, TransLoc 3D
Regular price $149.00 USDRegular priceUnit price / per