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), K052917, STRYKER COMPARTMENTAL KNEE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K060149, SUNIPAN IMAGING SYSTEM & ACCESSORIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K053536, DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051093, OSTEOPORE PCL SCAFFOLD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K060515, DEPUY PFC SIGMA KNEE PROSTHESIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052457, PICSI SPERM SELECTION DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K060865, BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061095, AUTO SUTUR ENDO GIA STAPLERS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061035, TIGERVIEW PROFESSIONAL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061312, 36MM BIOLOX DELTA CERAMIC HEADS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052601, STOCKERT HEATER-COOLER SYSTEM 3T
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061058, NEOZOLINE VENTILATION TUBES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K053656, TYRX ANTIMICROBIAL MESH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061243, SMITH & NEPHEW MODULAR FEMORAL HEAD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061556, AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061247, DIASORIN LIAISON TREPONEMA ASSAY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061226, TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061425, PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL PW1201-01;PUREWRIST HOOK, MODEL PW1301-01
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062259, ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061555, ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061248, AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062315, SUPERDIMENSION/BRONCHUS PREMIUM 2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062408, SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062385, BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061145, SPERMSLOW
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061996, SANDMAN POCKET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062386, QANGIO CT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062481, SERENO ELECTRONIC STETHOSCOPE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062251, REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062967, CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K053225, CELLU M6 KEYMODULE I
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061718, INNOVACON SPECTRUM II TEST CARD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063204, SPIDERFX EMBOLIC PROTECTION DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063158, SYNTHES ANTEGRA SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061533, PROCEED VENTRAL PATCH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062426, DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
Regular price $149.00 USDRegular priceUnit price / per