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), K093296, ALEXIS LAPAROSCOPIC SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112666, SALINE WOUND WASH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152568, C-VBR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151482, BCR-30-min BI™ and RBIP-ST30™ Readout Accessory
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080133, MOUNTABLE ENDOSCOPIC BLADE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061331, ORAL BALANCE LIQUID/ GEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062653, MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072306, BIOXTRA MOISTURIZING GEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160644, Lelo Hex Natural Rubber Latex Condom
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152086, 3Shape Ortho System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080399, DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040262, DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091799, CABLE READY CABLE GRIP SYSTEM CABLE BUTTON
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120772, NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092178, AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082750, ENTACT SEPTAL STAPLER, MODEL 610-00100
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151372, Low Dose CT Lung Cancer Screening Option for Qualified GE Systems
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153444, Philips Multislice CT System with Low Dose CT Lung Cancer
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K102511, MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082205, FACTOR VIII ANTIBODY SCREEN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K993553, GTI-FVIII INHIBITOR ASSAY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K134032, ULTHERA SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132028, ULTHERA SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122528, ULTHERA SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161210, RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123329, DA VINVI SURGICAL SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141077, DA VINCI FIREFLY IMAGING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113610, ANA-SCREEN WITH MDSS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K070612, TOP-RANK ADHESIVE ELECTRODE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072076, CYTOPLAST PTFE SUTURE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160744, LOOK PTFE Suture
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153088, AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152572, AXIOS Stent and Delivery System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150692, AXIOS Stent with Electrocautery Enhanced Delivery System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140561, AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140737, STRAUMANN CARES SCREW RETAINED BARS/BRIDGE
Regular price $149.00 USDRegular priceUnit price / per