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), K011168, NEUROGEN NERVE GUIDE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142461, VASCU-GUARD Peripheral Vascular Patch
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K983007, NEUROTUBE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K103081, COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131036, YAMAHACHI DENTURE BASE RESINS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101889, DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201290, Medline DeNovo 4Pro Electrical Stimulation Device
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080950, STIWELL MED4
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143577, XW-100 Automated Hematology Analyzer, XW QC CHECK
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201418, Sunset Heated CPAP Tube
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K213037, IDx-DR v2.3
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K972699, AESOP 3000 SYSTEM AND ACCESSORIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K191272, Wearable Device, Wearable Package
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K023984, MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201832, Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152848, AUTOLAP SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002970, SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K031799, MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K202406, Butterfly iQ Ultrasound System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K213620, ATUSA™ Automated 3D Breast Ultrasound System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212616, Koios DS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K190442, Koios DS for Breast
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212871, Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161487, VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071079, SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001401, AMT THERAPEUTIC TABLE, MODEL 748AMT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090209, HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162540, INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K010455, ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111822, STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K193067, The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K181661, QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K201806, Reprocessed PentaRay Nav eco High-Density Mapping Catheter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K190610, Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220411, Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220426, Fiber Dust PRO
Regular price $149.00 USDRegular priceUnit price / per