Collection: Fast Track Requests
FDA documents available for fast-track requests typically delivered within 1 to 2 weeks. Our fast-track request service identifies previously requested and redacted documents for quick access.
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below to find the documents you are looking for by common criteria such as name, company, classification, date, etc.
below to find the documents you are looking for by common criteria such as name, company, classification, date, etc.Can't find what you are looking for? Submit a Custom Request.
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FDA Inspections CSV – May 1, 2024 to November 1, 2024 (Company Name, FEI, End Date, CPGM Code)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Inspections Spreadsheet – Qingdao Biopeptek, Hubei JXBio Pharmaceutical, & Sinopep-Allsino Biopharmaceutical (Since January 2019)
Regular price $69.00 USDRegular priceUnit price / per -
FDA CSV Listing of Inspections (07/01/2024–10/31/2024) – Including FEI, Dates, Legal Name, Address & More
Regular price $69.00 USDRegular priceUnit price / per -
FDA Phytolon Two-Color Petition Submission Documents – CAP-4C0326 (Docket No. FDA-2024-C-1085) & CAP-4C0332 (Docket No. FDA-2024-C-3229)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Trade Complaints – Amarin, Vascepa, REDUCE-IT & Placebo Issues
Regular price $69.00 USDRegular priceUnit price / per -
FDA Cosmetic Facility Registration Report Update
Regular price $69.00 USDRegular priceUnit price / per -
FDA Submission Data – 510(k) K992799 (Biomerica, Inc.)
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510(k) Premarket Notification – ProNephro AKI™ (K232761)
Regular price $69.00 USDRegular priceUnit price / per -
Full 510(k) Record – K231325 (with AI requests & Amendments, StimLabs)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Premarket Notification – Multiple Submissions (K230111, K170874, K192004, K213794, K173156)
Regular price $69.00 USDRegular priceUnit price / per -
Clinical Trial Records – NeuroStar Advanced Therapy System (K212289, predicate K193006)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Submission – NuVasive Precice Intramedullary Limb Lengthening System (K220234)
Regular price $69.00 USDRegular priceUnit price / per -
Full 510(k) File – K231325 (Complete Premarket Notification)
Regular price $69.00 USDRegular priceUnit price / per -
Full 510(k) Record – i-STAT CHEM8+ & epoc Blood Analysis Systems (K191360, K200107)
Regular price $69.00 USDRegular priceUnit price / per -
FDA & Noah Medical – Galaxy System Correspondence (Post-K223144)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Submission – K230476
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Submission – Olympus (K182408)
Regular price $69.00 USDRegular priceUnit price / per -
Request – Bactiseal Catheters & Accessories (K233445, with correspondence)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Device Request – ROSA® Shoulder System (K233199, Decision 02/21/2024)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Submission Request – PROTECTED BRONCHOALVEOLAR Lavage Balloon Catheter (K910536, Mill-Rose Laboratory)
Regular price $69.00 USDRegular priceUnit price / per -
SAP – KidneyIntelX.Dkd (DEN200052, Renalytix AI, Inc.)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Documentation – CanGaroo RM Antibacterial Envelope (K233991, Elutia, Inc.)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Submission Documents – K955650
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Complete Copy – StimLabs, LLC (K231325)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Full Version – EXTENDED LIFE CAPD Transfer Set (K152675)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Applications & Approvals – Electronic Waveform Inc. (Multiple K Numbers)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Submission – NextDent Base (K231388, Vertex-Dental B.V.)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Submission – Ivotion Base Print (K233995, Ivoclar Vivadent, Inc.)
Regular price $69.00 USDRegular priceUnit price / per -
Performance Plan – AeroChamber Plus Flow-Vu (K181649)
Regular price $69.00 USDRegular priceUnit price / per -
Records – FDA 510(k) Submission K172959
Regular price $69.00 USDRegular priceUnit price / per -
Request – Redacted Copies of 510(k)s (K130896 & K981624)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Submission Records – PSM LOMAS / BENEFIT SCREWS (K110392)
Regular price $69.00 USDRegular priceUnit price / per -
Request – 510(k) Submission Records for Enspire 3000 (K230930, STERIS Corporation)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Contents – FERTILITE OV (K020808, Pheromone Sciences Corporation)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Contents – CLEARPLAN EASY FERTILITY MONITOR (K981207, Unipath Ltd.)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Contents – Instant-View LH Ovulation Predicting Test (K022829, Alfa Scientific Designs, Inc.)
Regular price $69.00 USDRegular priceUnit price / per