Collection: Fast Track Requests
FDA documents available for fast-track requests typically delivered within 1 to 2 weeks.
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FDA Device Info: SILVADURTM PMA Materials
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: FIGS, Inc. PMA Materials
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: K3 Lightweight Wheelchair Records
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: Enforcement Records for Neuma Innovations
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: 510k for BRUTM
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: Records for welloStationX
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: Kimberly-Clark's 510k Submissions
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: Records Regarding Philips Recalled Devices
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: 20 Years of Predicate 510k Numbers
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: Testing Data for Low Profile Balloon Feeding Device
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: Anondyne Docs and Info
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: Zeller Power Products 510k Info
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: List of Predicate Devices with Claimed Equivalence
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: Alydia Health 510k Clinical Study Report
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: IVC Filter PMA Decision Memos
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: IVC Filter 510k Decision Memos
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: List of Pre-Market Submissions
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: Reviewer Notes Parietex 510ks
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: List of Devices Cleard by PMA Pathway
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: list of Single Use Devices
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: List of New 510k Devices Approved
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K961321, GAMMA GUIDANCE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133209, FORESEE (4C) IMAGING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083475, LUCENT MAGNUM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141316, COGNISION EEG/EP SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042600, STANSION MATRIX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K081331, FIXXSURE CROSS LINK
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111166, A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133340, SPINEWORKS ANTERIOR LUMBAR DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061079, MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K863920, WAKO(TM) ZN TEST
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200225, Arctic Sun Stat Temperature Management System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161602, Arctic Sun Temperature Management System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142702, Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101092, ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071341, MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
Regular price $149.00 USDRegular priceUnit price / per