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), K082385, CHAPERON GUIDING CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K081960, INVISALIGN SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083091, LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083839, AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082996, BIOLOX DELTA OPTION CERAMIC HEADS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083691, BONEVUE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082623, VISIX IMAGING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083762, BIOLOX DELTA CERAMIC FEMORAL HEADS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083763, ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083802, SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082819, DERMATOLOGIC TREATMENT SYSTEM (DTS) G2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062187, BETACHEK GLUCOSE TEST
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082227, MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090244, SWIFT FX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090413, A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090094, ZELTIQ SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090037, MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083716, FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082367, INFANT SLEEP BEANIE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091641, HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083903, 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091760, DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090224, FORTEX PEDICLE SCREW SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083707, ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091633, TEPHAFLEX SURGICAL FILM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082391, PRIMAEVA MEDICAL RENESIS SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092365, INREACH SYSTEM, MODEL AAS00161-02
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091135, RUTTER SUPRA STOMAL STENTS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091781, GUIDED MEDICAL POSITIONING SYSTEM (GMPS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092283, DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091499, MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092150, COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092090, ERBELIFT HAND PUMP AND FLEXIBLE PROBE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091457, NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091051, BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082588, GAMMALOC SYSTEM, MODEL 03-00001
Regular price $149.00 USDRegular priceUnit price / per