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), K202546, LVivo Seamless
Regular price $367.15 USDRegular priceUnit price / per -
FDA 510(k), K220951, PMT Facet Fixation System (PMT FFS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121289, LTM-LABAROSCOPIC SURGICAL MESH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K171392, ulrichINJECT CT motion
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K193419, MBT Sepsityper
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K192665, Accelerate Pheno System, Accelerate PhenoTest BC Kit
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050002, VITEK 2 COMPACT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201404, Passio Pump Drainage System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K190292, Passio Pump Drainage System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K193293, XV Lung Ventilation Analysis Software
Regular price $765.00 USDRegular priceUnit price / per -
FDA 510(k), K201898, Clear Guide SCENERGY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201188, Clear Guide SCENERGY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101589, BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212657, Quantum Heater-Cooler
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071986, LTM-RC SURGICAL MESH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K070560, LRTM SURGICAL MESH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K210133, Current Health Monitoring System Gen 2 (G2)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K944699, ATT-300
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212815, My3D® Personalized Pelvic Reconstruction
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122702, BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
Regular price $1,080.74 USDRegular priceUnit price / per -
FDA 510(k), K183385, NanoKnife System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K172633, INFINITY Total Ankle System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K181557, INFINITY Total Ankle System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K221007, cobas HCV
Regular price $1,256.00 USDRegular priceUnit price / per -
FDA 510(k), K211347, Uretero1 Ureteroscope System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K222166, SOLIX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K926424, CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K221183, AEYE-DS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212767, SleepRight Select-Comfort Dental Guard
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K191033, LunaGuard Nighttime Dental Protector
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212706, SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011584, MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K943537, MODEL 3470 X-TREL RF RECEIVER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K213857, HeartFlow Analysis
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K192662, CapsoCam Plus (SV-3) Capsule Endoscopy System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K974303, INFANT FLOW SYSTEM
Regular price $149.00 USDRegular priceUnit price / per