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), K061903, RELIEVA SINUS BALLOON CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K073041, RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143541, Relieva SpinPlus Balloon Sinuplasty System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140160, RELIEVA SCOUT SINUS DILATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093737, HEMOSIL F11 & FV DNA CONTROL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063224, GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153341, Relieva Scout Multi-Sinus Dilation System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151964, Xprecia Stride Coagulation System, Xprecia System PT Controls
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112368, CAPNOSTREAM20P WITH AI/ODI
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101995, CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141833, STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K031377, SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K094041, ALPHA ORTHOPAEDICS AT3 SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153549, OSSIX VOLUMAX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160237, Cefaly
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153707, Nihon Kohden Vital Sign Telemeter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K103787, MEDEOR MATRIX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K873604, E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142494, ViMove
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K020701, SYNCRUS INTERNAL CARDIOVERSION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K041604, MACRO-MICRO DEPTH ELECTRODE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K053358, DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K053363, DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072601, OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030427, HP-3 HD ELECTRIC WHEELCHAIR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101677, HOSPIRA INFUSION BLOOD SETS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K022617, COMFY HIGH RISER WHEELCHAIR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K031342, JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K032123, SHOCKWAVE SUSPENSION WHEELCHAIR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062532, ELECTROPULSE - LOW BACK PAIN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K031128, B-SMART, MODEL B-01
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082008, BIONET BM3PLUS PATIENT MONITOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130740, NIGHTINGALE MONITORING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030419, VITERION 100 TELEHEALTH MONITOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123262, OPTIFLUX ULTRA DIALYZER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160754, Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)
Regular price $149.00 USDRegular priceUnit price / per