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), K091459, PHILIPS NM3 MONITOR, MODEL 7900
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161605, Smart External Drain (SED) System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K192324, Sheridan Spiral-Flex Endotracheal Tubes
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212412, IRIS-XP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140300, COLLAGEN TENDON SHEET-DDI (CTS-DDI)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201572, TAPESTRY Biointegrative Implant
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K213958, Bioabsorbable Anchor
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K190545, VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K193423, VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220867, Tapestry Biointegrative Implant
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200596, G21 Cement, VADER® Pedicle System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071553, ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063654, ENDOGUIDE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151358, AZUR CX Detachable 35 Coils
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120630, AZUR DETACHABLE 18
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062049, EVIS EXERA II 180 SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092622, STERRAD 100NX STERILIZER EXPRESS CYCLE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K181240, Rhino-Laryngo Fiberscope Olympus ENF-GP2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K181451, URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K032514, AC APPLICATOR, AURORA AC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212947, Trinity Plus Wrinkle Reducer
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K192349, Bactisure Wound Lavage
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161165, Next Science Irrigation Solution
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K210536, Irrisept Antimicrobial Wound Lavage
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K202222, Irrisept Wound Debridement and Cleansing System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K202071, SURGIPHOR Wound Irrigation System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161623, Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212658, CloudCath Peritoneal Dialysis Drain Set Monitoring System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K020608, HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101262, FLEXI-LITE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K171899, Revitalair 430F
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140510, MIROMATRIX WOUND MATRIX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160136, Flowable Wound Matrix
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K021827, MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152967, NERBRIDGE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162741, AxoGuard Nerve Connector
Regular price $149.00 USDRegular priceUnit price / per