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), K000609, CARDTEL, MODEL NT-100
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K000795, RIGID GAS PERMEABLE CONTACT LENS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K000669, MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001217, INSIDE VIEW
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001989, COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002321, PAIN CARE 2000L
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001960, RIGID GAS PERMEABLE CONTACT LENS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002138, PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001149, AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002255, LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002883, PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002913, HEADBAND FOR BAHA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003335, RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001520, ALPHA OMEGA DUAL COOLER-HEATER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003028, CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002996, SYNERGY HA COATED POROUS FEMORAL STEMS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003337, HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003305, PEDIATRIC INGESTASCAN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003269, UNICONDYLAR INTERPOSITIONAL SPACER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003154, MIZAR, BASIS BE, SANDMAN DIGITAL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002488, KELO-COTE TOPICAL GEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003487, STIMATE N601 TENS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003789, SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002095, SNAP MODEL 6
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K000881, PERFADEX SOLUTION FOR ORGAN PRESERVATION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003987, URS-1K (KETONE TESST)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003559, TCI (TINNITUS CONTROL INSTRUMENT)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K010993, ALIEN RX MICRO CANNULA, MODEL 4530
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K010460, LIFELINES TRACKIT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011149, DISPOSABLE BENDING CANNULA PR-233Q
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011369, ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011366, CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011364, CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011071, PARADIGM QUICK-SET INFUSION SET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011566, QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011291, TEMPORALSCANNER THERMOMETER, SENSORTOUCH
Regular price $149.00 USDRegular priceUnit price / per