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), K141932, AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K170974, BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK
Regular price $1,674.69 USDRegular priceUnit price / per -
FDA 510(k), K190593, Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K191804, TOMi Scope
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163512, Zio AT ECG Monitoring System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K210478, 8mm Monopolar Curved Scissors
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072002, FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K791307, UNIPOR BREATHING CIRCUIT FILTER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K980298, FLOWABLE HYBRID
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212180, Wearable Breast Pump (Model S12)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K211024, Electric Breast Pump
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212955, Fit Pro Breast Pump
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212773, ARDO Alyssa
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212564, Electric Breast Pump
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220596, Wearable Breast Pump (Model S9)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K192764, NeuroOne Cortical Electrode
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K960047, BRANNON PEDI PORTSYRINGE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K960049, BRANNON PORTSYRINGE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K965030, BRANNON ARTERIO-VENOUS PORTSYRINGE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K183635, PhotoFix Decellularized Bovine Pericardium
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K213606, EvoEndo Single-Use Endoscopy System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K213833, SCOPE BUDDY PLUS Endoscope Flushing Aid
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220641, Barrigel Injectable Gel
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201977, TempTraq
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K181038, CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K193576, Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142983, AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K192731, ZIDA Wearable Neuromodulation System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092219, NAVIGATOR CLINICAL GUIDENCE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K211222, qER-Quant
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K180165, Habib EndoHPB
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083292, HABIB ENDOHPB
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162128, Scope Buddy Plus Endoscope Flushing Aid
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220195, iFuse Bedrock Graniteā¢ Implant System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212045, SoftSpot
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072020, RESTORATION ADM SYSTEM
Regular price $149.00 USDRegular priceUnit price / per