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), K142881, DMRC Dual Cure Orthodontic Band Cement
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143705, NeedleCam HD Visualization System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143191, IntelliSense Drill
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150499, Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142282, HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143714, Powerheart G5 AED
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142319, SCIg60 Infuser, Infuset
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150151, SmartGownTM surgical gown
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150271, Prime Adaptive Ultrasonic Scalpel System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143496, Piccolo Composite Plate System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143263, Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150042, PleuraFlow System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151115, MR Core Software
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151340, HARMONIC Focus Long Shears + Adaptive Tissue Technology
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150850, Refobacin Bone Cement R
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150906, ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151363, Zephyr Vascular Compression Device
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151204, HEMO-Bandage
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150685, Skynector CPAP Mask
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151324, Straumann Variobase for CEREC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152309, LOGIQ E9, LOGIQ E9 XDClear 2.0
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151777, Intradermal Adapter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150222, X-Guide Surgical Navigation System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151988, Visible Patient Suite
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142505, ClearPoint System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143306, ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151376, superDimension Navigation System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150386, Tyece OTC TENS Device
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150219, Equashield Closed System drug Transfer Device (CSTD)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152060, 3M Attest Rapid Readout Biological Indicator 1295
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151926, QuickRay HD Intraoral Sensor
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152857, NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152491, MoMe Software Platform
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151662, iRestore
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153618, Capillus202
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152311, Pentacam AXL
Regular price $149.00 USDRegular priceUnit price / per