Collection: Products
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24FDA1007 - K211786 - Estimated Agency Fee
Regular price $551.00 USDRegular priceUnit price / per -
483 Report – ALOM Technologies Corporation Inspection (Indianapolis, IN, 10/17/2024)
Regular price $69.00 USDRegular priceUnit price / per -
483 Report – Apnea Sciences Corporation Inspection (Aliso Viejo, CA, 9/18/2024)
Regular price $69.00 USDRegular priceUnit price / per -
483 Report – Assut Europe S.p.A. Inspection (Magliano De' Marsi, Italy, 9/26/2024)
Regular price $69.00 USDRegular priceUnit price / per -
483 Report – Biocon Biologics Limited Animal Health Inspection (Bengaluru, India, 2/28/2024)
Regular price $69.00 USDRegular priceUnit price / per -
483 Report – CosmoFrance, Inc. Inspection (Miami, FL, 9/16/2021)
Regular price $69.00 USDRegular priceUnit price / per -
483 Report – Glottal Enterprises Inc. Inspection (Syracuse, NY, 10/20/2024)
Regular price $69.00 USDRegular priceUnit price / per -
483 Report – Haupt Pharma Latina S.r.l. Animal Health Inspection (Italy, 2/21/2024)
Regular price $69.00 USDRegular priceUnit price / per -
483 Report – LOHMAN TECHNOLOGIES LLC Inspection (Pewaukee, WI, 9/27/2024)
Regular price $69.00 USDRegular priceUnit price / per -
483 Report – Lydia Hernandez, M.D. Inspection (Cincinnati, OH, 9/17/2024)
Regular price $69.00 USDRegular priceUnit price / per -
483 Report – Massachusetts Dept of Mental Health CRRC Inspection (Boston, MA, 8/28/2024)
Regular price $69.00 USDRegular priceUnit price / per -
483 Report – Nanjing White Whale Pharmaceutical Co. Animal Health Inspection (1/25/2024)
Regular price $69.00 USDRegular priceUnit price / per -
483 Report – PB&M Brands, LLC Inspection (Sarasota, FL, 3/8/2022)
Regular price $69.00 USDRegular priceUnit price / per -
483 Report – Randy D. Hicks, M.D. Inspection (Flint, MI, 9/12/2024)
Regular price $69.00 USDRegular priceUnit price / per -
483 Report – Sarasota Medical Products, Inc. Inspection (Sarasota, FL, 9/12/2024)
Regular price $69.00 USDRegular priceUnit price / per -
483 Reports & Correspondence – CareFusion 303, Inc. (Inspection 5/22/2024; Warning Letter 11/22/2024)
Regular price $69.00 USDRegular priceUnit price / per -
483 Reports – Animal Health Inspections: Rancher's US OP LLC & Talley Farms Feed Mill Inc.
Regular price $69.00 USDRegular priceUnit price / per -
483 Reports – Concentrics Research (Human Drugs) & Boothwyn, Ohio Pet Foods, Byrne Farms (Animal Health)
Regular price $69.00 USDRegular priceUnit price / per -
483 Reports – HepQuant & Philips North America Inspections
Regular price $69.00 USDRegular priceUnit price / per -
483 Reports – Portable Therapeutix & Pathy Medical Inspections
Regular price $69.00 USDRegular priceUnit price / per -
483 Reports – Viant AS&O Holdings & Neuronetrix Solutions Inspections
Regular price $69.00 USDRegular priceUnit price / per -
483 Request – Ceva Animal Health, LLC Inspection (Oldsmar, 11/09/2018)
Regular price $69.00 USDRegular priceUnit price / per -
483 Responses – iRhythm Technologies
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) Clearance – ECTOBRAIN CORR (Somatics LLC)
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) Contents – CLEARPLAN EASY FERTILITY MONITOR (K981207, Unipath Ltd.)
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 – Instant-View LH Ovulation Predicting Test (K022829, Alfa Scientific Designs, Inc.)
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) Documentation – CanGaroo RM Antibacterial Envelope (K233991, Elutia, Inc.)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Documents – spaceOAR (DEN140030) Submission Records & Regulatory Materials
Regular price $69.00 USDRegular priceUnit price / per -
510(k) File – Auris Health Monarch Platform, Urology (K213334)
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) Premarket Notification – Multiple Submissions (K230111, K170874, K192004, K213794, K173156)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Premarket Notification – ProNephro AKI™ (K232761)
Regular price $69.00 USDRegular priceUnit price / per