Collection: FDA 510(k)
FDA 510K documents available for fast-track requests typically delivered within 1 to 2 weeks. Publicly Available documents delivered within 24 business hours.
Use Search below to find the 510k you are looking for by:
- Device Name
- Manufacturer
- Device Classification Name
- Regulation Number
- Classification Product Code
- Date Received
- Decision Date
- Regulation Medical Specialty
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FDA 510(k), K151901, AirView
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140054, RESCAN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K182741, SculpSure
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K210575, HDF Assist Mudule, HDF Infusion Set and Substitution Filter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K973865, BIRTCHER UV LAMP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K211389, Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K203735, Brainsway Deep TMS System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K180367, Ureterorenoscope System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K190648, Pusen Eview Medical Video Endoscope Image Processor
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K181977, WiScope Digital Endoscope System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K952638, 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K934696, ANGIOSCOPE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K931464, BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE
Regular price $241.74 USDRegular priceUnit price / per -
FDA 510(k), K923996, DISPOSABLE VASCULAR ANGIOSCOPE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K914570, DISPOSABLE VASCULAR ANGIOSCOPE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K913129, ANGIOLAZ ANGIOSCOPE CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K060269, ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201158, NeuroStar Advanced Therapy
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K990358, CROSS SPORT, RIGID WHEELCHAIR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200247, Fusion Quattro Extraction Balloon
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K183376, HORIZON TMS Therapy System with Navigation
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011533, DEPUY FEMORAL HEADS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K182853, HORIZON TMS Therapy System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K182700, Nexstim Navigated Brain Therapy (NBT) System 2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K173620, Mag Vita TMS Therapy System w/Theta Burst Stimulation
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K010675, ENSIL FABRIC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K823737, MADE-TO-MEASURE SURGICAL ELASTIC SUPPORT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113871, PRO-DENSE BONE GRAFT SUBSTITUTE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K183598, KeyPrint KeySplint Soft
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201346, DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130255, HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K103792, BARCO MAMMO TOMOSYNTHESIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161229, Mammo Tomosynthesis (MDMG-5221)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K191080, Ambu aScope 4 RhinoLaryngo Slim
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K943540, SURGICAL CUTTING BURS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K213208, Twist Drills
Regular price $149.00 USDRegular priceUnit price / per