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), K142743, AliveCor Heart Monitor
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160064, MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152701, Matrix Mini ECG Monitor
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061232, ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083103, ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142718, Radlink GPS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113449, FUSION FLAT PANEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071132, G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K022845, SAS RSV TEST
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151321, D-100 HbA1c, D-100 HbA1c Calibrator Pack
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160526, Masimo O3 Regional Oximeter System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111068, STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152319, Auris Robotic Endoscopy System (ARES)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111202, SURGICAL TISSUE MANAGEMENT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152473, CAS-One IR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121597, ESON NASAL MASK
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123637, HAMILTON-C3
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093416, TRILOGY 200 VENTILATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093905, TRILOGY 202 VENTILATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130542, SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142521, Synapse 3D Liver and Kidney Analysis
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120361, SYNAPSE 3D BASE TOOLS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143404, SurgiQuest AirSeal iFS System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133981, AVACEN 100
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003128, MODIFICATION TO RELIEF BRIEF
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K953442, RESTORE, THERMACELLS (HOT PACK I)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052846, TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090141, PRONTOSAN ANTIMICROBIAL WOUND GEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133022, ZEDVIEW
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K761179, PSORALITE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011034, SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K012634, REPROCESSED EXTERNAL FIXATION DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113770, ORTHOFIX GALAXY FIXATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051188, GRAFTON DBM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122513, CLEARED UNDER GRAFTON II EDBM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123691, MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
Regular price $149.00 USDRegular priceUnit price / per