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), K151789, LOCATOR F-Tx Attachment System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122424, ISUS IMPLANT SUPRASTRUCTURES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062961, MICROLUX TRANSILLUMINATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101423, OPTIBOND XTR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K990498, OPTIBOND SOLO PLUS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K014027, OPTIBOND SOLO PLUS 4
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130991, NEXXZR(TM)T AND NEXXZR(TM)S
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153309, BD Vacutainer UltraTouch Push Button Blood Collection Set
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111421, SIRONA DENTAL CAD/CAM SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152911, EarlySense Insight Sytem
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161509, 3D OCT-1 Maestro
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160056, t:slim Insulin Delivery System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152276, Wing Smart FEVI and Peak Flow Meter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K110116, XEROS DRY MOUTH PUMP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091106, EQUIA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K103646, INTELLIVUE MX40 PATIENT MONITOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111441, UNIMAX VERESS NEEDLE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141167, VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152139, Vital Connect Platform, HealthPatch MD, VitalPatch
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090633, LENSAR LASER SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130419, PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061051, DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052118, DOSE VERIFICATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040687, ONEDOSE PATIENT DOSIMETRY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151816, TLC-2000 Therapeutic Medical Laser System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153249, Pulpdent Solo Flowable Composite with MCP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160403, SmartStart Air/Water and Suction Valves
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161039, NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151491, Falck Medical Multifunction Tonometer, FAT1
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161421, Single Use Surgical Suction Irrigator
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120486, AVS AS PEEK SPACER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141421, PMMA BLOCK
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153753, TelioCAD Multi
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151764, YAMAHACHI PMMA DISKS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152802, Grasping Forceps
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120084, ENDOSCOPIC RETRIEVAL DEVICE
Regular price $149.00 USDRegular priceUnit price / per