Collection: Fast Track Requests
FDA documents available for fast-track requests typically delivered within 1 to 2 weeks.
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FDA 510(k), K173087, UroLift System (UL400 and UL500)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K211228, Rosso
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K020566, FUJIREBIO DIAGNOSTICS CA 19-9 RIA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131230, GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141656, GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150299, Gmate SMART Blood Glucose Monitoring System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151658, Gmate Origin Blood Glucose Monitoring System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113636, BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K862810, COMPANION 2500 PORTABLE VOLUME VENTILATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K223726, Aquilion Precision (TSX-304A/4) V10.14 with AiCE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K213794, Eko Murmur Analysis Software (EMAS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160360, Barrx FLEX RFA Energy Generator
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220540, ProGrip Self-Gripping Polypropylene Mesh
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K221131, Tasso+
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K221303, Neuspera Nuity System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101170, ACUTE INNOVATIONS STERNAL FIXATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K895753, BREVET DISPOSABLE CONNECTORS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K202874, Puritan Bennett Cuff Pressure Manager
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K210541, ulrichINJECT CT motion
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K192048, Single Use Endoscope Valves Set
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K812672, SELF-CENTERING HIP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212632, ClotTriever Thrombectomy System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K192833, Indigo Aspiration System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K210911, WOLF Thrombectomy System, 14F
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K213565, JETi AIO Peripheral Thrombectomy System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201705, ReVene Thrombectomy Catheter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011056, ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130904, TRELLIS-8 PERIPHERAL INFUSION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K211798, Cleaner Plus Thrombectomy System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K191419, Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K214114, Prodigy Thrombectomy System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K190793, Tablo Hemodialysis System, Tablo Cartridge
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K221320, Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K222200, CIRRUS HD-OCT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K110306, SOUND SURGICAL VASER 2.1 LIPO SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K904774, INGLAT-O-BALL
Regular price $149.00 USDRegular priceUnit price / per