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), K091411, KNEEALIGN SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133482, SILC FIXATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143350, Nile Alternative Fixation
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K971125, ENDO SMARTCAP (100501)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093665, ENDO SMARTCAP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113088, HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K013705, ACT III VENTRICULAR CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150776, Medrobotics Flex System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141081, FILTEK BULK FILL POSTERIOR RESTROATIVE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050418, TISSUE FIXATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141704, NOVASHIELD INJECTABLE NASAL PACKING AND STENT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141816, HEMOPORE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141837, DRX-EVOLUTION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132403, ANNEXTM ADJACENT LEVEL SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082626, PAM 3000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150910, ACCU-CHEK Connect Diabetes Management App
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141929, ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151236, MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132423, THE GYNOCULAR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132733, ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131251, TRINITY ELE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130065, BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142794, Everyway Facial MENS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080949, KERATEC WOUND DRESSINGS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112174, NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K110586, ADVIA CENTAUR VITAMIN D TOTAL ASSAY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K110619, ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113546, ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150912, Houva-NET Control System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123212, ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122797, ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141153, LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150641, MagVita TMS Therapy System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141288, VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133237, GEL-BEAD EMBOLIZATION SPHERES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K010315, ISCREEN VISION SCREENER
Regular price $149.00 USDRegular priceUnit price / per