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), K111763, PATHASSIST LIGHT FIBER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112226, HYDROCOIL EMBOLIC SYSTEM (HES)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111904, ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112249, HEALIX KNOTLESS(TM) ANCHOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112844, REHASTIM 2, REHAMOVE 2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111010, SPIDERFX EMBOLIC PROTECTION DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112205, SNORERX 9.0
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111773, RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113201, NARVAL CC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113500, CANADY VIEIRA HYBRID PLASMA SCALPEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112437, ARTHREX FRACTURE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111717, ELECTRO-GEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K110888, ABSOLUTE WHITE LIGHT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113294, SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113663, SONIXTABLET ULTRASOUND SCANNER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113259, NOTOUCH BREASTSCAN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K110179, INCONTROL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120301, MEDIGUIDE TECHNOLOGY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113872, THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120593, MYOSURE CONTROL UNIT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112422, CRAG LATERAL FLOW ASSAY (LFA)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120238, RTVUE XR OCT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120187, MULTI-MODALITY IMAGE FUSION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113796, SOLITAIRE-C CERVICAL SPACER SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111250, DRY MOUTH MOUTHWASH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112909, OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112549, IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121166, WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120298, CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120257, MLS, ZERONA-AD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120216, GENOSYL MV-1000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111862, VIEWRAY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121074, SCENIUM 2.0
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112860, PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120562, PERFORMAX PEDIATRIC EE TOTAL FACE MASK
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122086, THERMAL LIGATING SHEARS
Regular price $149.00 USDRegular priceUnit price / per