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), K132750, ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131482, SOFIA DISTAL ACCESS CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130135, DANA REUSABLE BI TEST PACK
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131897, CV3000 HOLTER ANALYSIS SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132848, PIEZOSURGERY FLEX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133314, HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132429, SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121248, LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133281, NEOTRACT UROLIFT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131447, INTUITION - TDA, TVA, PARAMETRIC MAPPING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133520, HAMMERLOCK 2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132660, NERVE CUFF
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133499, SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131799, QUICKNIT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133950, ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132839, FUSE 1C COLONOSCOPY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131260, NMI DIALYSIS CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133948, BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132219, STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131252, PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133858, TENSYN BAND
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133715, CHARLOTTE CLAW PLATE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131433, ISYS 1 (U.S),ACCESSORY, NON-STERILE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133764, CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140345, THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140415, MONOTEX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140106, S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140131, SUB-Q SUBCUTANEOUS TISSUE INFUSION SET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140043, DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131541, FLEXIBLE COOAGEN NERVE CUFF
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133923, MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133705, REVOLUTION CT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140194, NAMIC RCS SYRINGE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133791, ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140625, ORTHOSORB LS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133941, MITEK ARTHROSCOPES
Regular price $149.00 USDRegular priceUnit price / per