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), K182417, ROSA ONE Brain Application
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151359, ROSA Brain
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200511, ROSA ONE Brain application
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K202781, Neuspera Neurostimulation System (NNS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K872048, TRANSONIC FLOWMETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200384, HipXpert 3D Display and Anchoring Application
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200918, SurgiWrap FROST
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K203450, EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K203024, C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K183603, INnate Cannulated Screw System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K073570, DEPUY TRI-LOCK BONE PRESERVATION STEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K000046, KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K033801, KYPHX HV-R, MODEL C01A
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K192423, MINT Product Family
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220549, MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130191, MINT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111738, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K211676, Motiva Flora SmoothSilk Tissue Expander
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030952, DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K013904, BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122278, BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140211, ULTRASONIC MESH NEBULIZER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K915075, NEBULIZER (DIRECT PATIENT INTERFACE)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001527, FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011041, WATERLASE, MILLENNIUM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111380, NEURON MAX SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072683, AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050843, AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K221868, QOCA image Smart CXR Image Processing System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K182870, Introcan Safety 3 Closed IV Catheter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220935, Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K060540, XPERT, GENEXPERT DX SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K012943, THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220560, Dermatac Drape
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K924953, FLUID COOLED BONE SAW BLADE, 6000 SERIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K222210, AEON Endoscopic Stapler
Regular price $149.00 USDRegular priceUnit price / per