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), K140763, MONOFILAMENT POLYPECTOMY SNARE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133879, FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133853, VIEWFLEX XTRA ICE CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132108, MAXIO
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133598, CARDIOHELP SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141104, TRUKLEAR BRACKET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140336, OPTIMUS FUSION: SLT, YAG AND YAG/SLT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140903, NUVIS ARTHROSCOPE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141049, IFUSE IMPLANT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141371, SONICISION CORDLESS ULTRASONIC DISSECTOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132983, TON-95LH, PAX-I3D ORTHO
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140919, RESPICONNECT ADAPTER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133895, DEKA SMARTXIDE LASER SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133983, INTRA. OX HANDHELD TISSUE OXIMETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141122, HARMONIC SCALLOP BLADE, GENERATOR G11
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141405, MOBIS II ST SPINAL IMPLANT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141935, STRYKER S2 DRILL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141894, SHARKCORE FINE NEEDLE BIOPSY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142160, LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142095, RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142079, STALIF CTI, STALIF C
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133997, LG SMARTHEALTH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133348, STIM PROBE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140382, AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141681, SYSMEX XN SERIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140847, CARDIOSPY ECG HOLTER SYSTEMS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141752, NXSTAGE SYSTEM ONE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142807, ANTHEM PS Total Knee System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133333, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141114, BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141921, HIVOX SPOPAD EMS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143182, Speedicath Compact Male
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141142, MAMMAPRINT FFPE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142940, Endoskeleton TCS System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142228, Heated Eye Pad
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140980, TI NASAL MASK
Regular price $149.00 USDRegular priceUnit price / per