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), K081092, MODIFICATION TO MAMMAPRINT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093549, 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090820, TRIA HAIR REMOVAL LASER SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082586, LIGHTWAVE PROFESSIONAL DELUXE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092224, TIGR SURGICAL MESH , MODEL WK-6
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091757, OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091283, CAPILLARYS NEONAT HB (PN 2006)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091496, MEP-90 HAIR GROWTH STIMULATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093677, STRYKER ARTHROSCOPE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093624, OPTISCAN MODEL OPTISCAN CEIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093930, DIDGET WORLD REPORTS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092944, DANA REUSABLE TEST PACK FOR STEAM STERILIZATION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093806, MYKNEE CUTTING BLOCKS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K094018, LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100412, BIOLOX DELTA CERAMIC FEMORAL HEADS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092602, FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100349, VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100099, ORAL/ENTERAL SYRINGES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093810, BF-NAVI
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101451, APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100902, AEDIS(TM)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100644, OPTOS LIMITED PANORAMIC 200CAF
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100441, XINIWAVE, MODEL XW-18
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093775, EVGUIDE TIP LOCATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101386, VIGILANT EEG MONITOR MODEL VIGILANT 2.0
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101561, TX1 TISSUE REMOVAL SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101810, 3DHJD CAMERA SYSTEM MODEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101834, 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101734, VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100787, RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K102219, SOCORRO SMI TUNNEL RELEASE DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101477, BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K102604, I-LOGIC INREACH SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101104, REMIN PRO
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K102217, SYSTEM 1E CHEMICAL INDICATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093565, PLEURAFLOW CATHETER SYSTEM
Regular price $149.00 USDRegular priceUnit price / per