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), K984254, INFANT FLOW NCPAP MASKS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K022023, COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K172574, SyncVision System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K222519, ClearPoint System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K214125, TRANBERG Thermoguide Therapy System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051263, EVITAXL WITH OPTION SMARTCARE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092156, CAD 12, COLONOSCOPY ASSIST DEVICE
Regular price $210.54 USDRegular priceUnit price / per -
FDA 510(k), K212382, Ambu® aScope™ Gastro, Ambu® aBox™2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K211785, CASSATT™ SIJ Fixation System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K790901, I.V. TUBING ORGANIZER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K210625, JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K192059, Bio Guard Air/Water & Suction Valves
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K203630, BioGuard Air/Water and Suction Valves
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K202104, BioGuard EUS Air/Water and Suction Valves
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K110457, 3M TEGADERM MATRIX DRESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K905069, IODOSORB GEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062925, COAGUCHEK XS SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200599, Digital Thermometer
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071176, MODIFICATION TO: ARTHREX INTERFERENCE SCREW
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062466, ARTHREX INTERFERENCE SCREW
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K970456, HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K173941, IntelliSpace Perinatal Rev.K.00
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K221047, SILO TFX MIS Sacroiliac Joint Fixation System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K210142, Fiber Dust
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201881, CoroFlow Cardiovascular System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K902783, PS MEDICAL DELTA CSF-FLOW CONTROL VALVE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212797, iPrime Viscodelivery System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K193319, XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091393, ELEKTA NEUROMAG WITH MAXFILTER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K953581, FIRST RESPONSE OVULATION PREDICTOR TEST
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K210554, Physica system
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212324, RenovoCath
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082930, CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K182149, FFRangio System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200776, Eko CORE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K962587, CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per