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
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- Device Classification Name
- Regulation Number
- Classification Product Code
- Date Received
- Decision Date
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FDA 510(k), K113565, MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122481, LIPIVIEW OCULAR SURFACE INTERFEROMETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K864959, OBF MODEL 112 VACUUM CUP SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143325, OC-Light S FIT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141012, HYDROCLEANSE WOUND CARE SOLUTION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122121, PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113657, INTELLIVUE PATIENT MONITOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083093, CHEETAH RELIANT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002533, TCD 100M, PWD13 TRANSDUCER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092164, TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K060112, NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122325, SKINTEMP II
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112423, COLLAGEN TENDON SHEET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091529, ICAD VERALOOK CTC CAD SOFTWARE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K972723, BIO TROL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083894, ALIF SPINAL TRUSS INTERBODY FUSION DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112316, 4-WEB ALIF SPINAL TRUSS SYSTEM (STS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121741, 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152437, BiowaveHOME Neuromodulation Pain Therapy Device
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141410, ORAGENE DX OGD-500.001
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062850, AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111825, ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150453, TULA Iontophoresis System with Earset
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112626, LIPSONIX(R) SYSTEM MODEL 2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100874, LIPOSONIX SYSTEM, MODEL 1 P00XXXX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143086, VX120 Ophthalmic Diagnostic Device
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113066, CORVIS ST
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101223, SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061373, VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K982816, VNUS CLOSURE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K974521, VNUS CLOSURE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153080, RTVue XR OCT Avanti with AngioVue Software
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101887, CONFIDENT SURGERY SUITE 300, MODEL CSS300
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121173, CHORD-X EPTFE SUTURE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140279, S9 GREENHILLS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150041, CORA (Coagulation Resonance Analysis) System
Regular price $149.00 USDRegular priceUnit price / per