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), K171022, Ablation Confirmation
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143538, MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091734, SONIC SHOT GX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141668, CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153645, VITA ENAMIC Implant Solutions (IS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072094, CHOOSTENT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K060743, MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151426, ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001338, MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071066, SPYCATCH STONE RETRIEVAL BASKET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K043401, SPECTRANETICS LLD CS, MODEL 518-039
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001275, RETCAM II
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K102082, EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K102581, DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K102409, DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121481, INFINI RADIOFREQUENCY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K882963, SPEMBLY MEDICAL 142 CRYO UNIT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K070374, ARTHROCARE ENT PLASMA WAND
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001408, KSEA VASCULAR FIBERSCOPES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K860812, SICKLE CELL REAGENT SET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K031327, VERICOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K970685, EARCHECK PRO
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160959, Xsert Lumbar Expandable Interbody System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133317, PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121396, DYNAFLEX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113618, CLEARCORRECT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K853126, BIO PACK MODEL 200
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160207, ATLANTIS ISUS Implant Suprastructures
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150550, SilverCoat Silicone Foley Catheter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K944939, CELEBRITY XL SC445
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K103175, FILMARRAY RESPIRATORY PANEL (RP)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131767, ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130380, ORTHOSENSOR KNEE BALANCER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161266, Athena Breast Pump
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K983067, FINE-JECT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K821537, HENKE DISPOSABLE SYRINGE
Regular price $149.00 USDRegular priceUnit price / per