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), K160294, SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152952, E-Cath
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K984358, OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130148, FOREIGN BODY HOOD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K012098, PRECLUDE PERICARDIAL MEMBRANE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K984534, PRECLUDE ACUSEAL DURA SUBSTITUTE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K021477, PRECLUDE MVP DURA SUBSTITUTE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K994267, FRESENIUS 2008K
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080964, FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K812639, UNICUFF
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K964152, UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143563, Infusion Aspiration Catheter System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K041219, ELECTRO
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072138, VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K974881, TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050891, TOX A/B QUICK CHEK
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K041003, IMMUNOCARD TOXINS A & B, MODEL 712050
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K935296, CLOSTRIDIUM DIFFICILE TOX-B TEST
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K102242, OSOM C. DIFFICILE TOXIN A/B TEST
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080931, VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K110203, XPERT C. DIFFICLE/EPI ASSAY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080838, ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040390, STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133751, DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143051, ArgenIS Titanium Abutments
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160248, ArgenIS Titanium Abutments
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K831004, AUTOMATED 8400 BLOOD CELL SEPARATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143014, F5
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083127, ASAHI CORSAIR MICROCATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101659, SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133539, TOTAL ACROSS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K960065, TEMNO DOUBLE SHOT BIOPSY NEEDLE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K935538, BAUER TEMNO COAXIAL NEEDLE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K902319, BAUER TEMNO BIOPSY NEEDLE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132021, AHP 300, EMERGENCY PORTABLE VENTILATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090170, SPYSCOPE ACCESS AND DELIVERY CATHETER
Regular price $149.00 USDRegular priceUnit price / per