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), K161897, PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K910875, ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K970788, PNEUMO-MATIC INSUFFLATION NEEDLE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121370, VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K921820, RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003901, ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151149, Ready-Fit
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K000180, TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152894, VIVIX-S 1717N
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161966, PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161459, Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161768, LUCAS 3 Chest Compression System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072234, THERMOGARD XP THERMAL REGULATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080899, ARCTIC BLAST INTRAVENOUS FLUID CHILLER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132290, SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042816, TRAUMACAD 1.2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072845, PRECISION FLOW
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143646, MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131895, AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111863, SIGNATURE PLANNER,SIGNATURE GUIDES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130387, ORTHOALIGN PLUS SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131278, MONTERIS MEDICAL NEUROBLATE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120561, NEUROBLATE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K081509, MONTERIS MEDICAL AUTOLITT LASER PROBE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123030, COMPRESSOR NEBULIZER MODEL MCN-S600XX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161201, ClearRead CT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K031861, MIX2VIAL TRANSFER DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123935, IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143153, EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093320, DRYODINE CADEXOMER-IODINE GEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K032644, KOLPEXIN SPHERE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K993308, MENTOR EVACARE VAGINAL PESSARIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K913749, EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100081, ENTEROSCOPY OVERTUBE, MODEL 00712140
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091773, FUJINON STERILE OVERTUBES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160295, SPROTTE NRFit, Quincke NRFit
Regular price $149.00 USDRegular priceUnit price / per