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), K212143, Neteera 130H/131H Vital Sign Monitoring Sensor
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050332, SURGI-WRAP MAST BIORESORBABLE SHEET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K192156, Cartiva SCI instrumentation set
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030797, S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K222476, OmegaAI Image Viewer
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K183078, VitalConnect Platform, VitalPatch Biosensor
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K103561, MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212156, ABCcolla Bone Matrix
Regular price $493.74 USDRegular priceUnit price / per -
FDA 510(k), K021481, BRESAGEN CATHETER, MODEL CS-3000
Regular price $218.00 USDRegular priceUnit price / per -
FDA 510(k), K223158, LigaSure™ XP Maryland Jaw Sealer/Divider
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K223548, GMK Sphere & GMK SpheriKA Cementless
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152533, Xonrid Gel
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K013056, GELCLAIR CONCENTRATED ORAL GEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153422, Panpac Disposable Pessary Fitting Set
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120781, CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K183045, Eclipse 2L
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K222012, FAQ 101
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220047, AcQCross Qx Integrated Transseptal Dilator/Needle
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150709, ProTrack RF Anchor Wire
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K172765, Smart Moves Complete
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212496, Ortho Aligner System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K180421, Natus NeuroWorks
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200878, Natus NeuroWorks
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090019, NATUS NEUROWORKS, MODEL 104196
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152494, Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments
Regular price $1,253.22 USDRegular priceUnit price / per -
FDA 510(k), K213854, SavvyWire
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K912645, Premarket Notification and Other Submitted Information
Regular price $262.54 USDRegular priceUnit price / per -
FDA 510(k), K202279, Insignis Subcutaneous Needle Sets
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K193601, Single Use Electrosurgical Knife
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200404, ORISE ProKnife
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K212237, 3D-Cut
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220997, Wireless TENS/EMS, Bruno, Aela
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121698, NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150160, Temple Touch Pro (TTP) Non-invasive temperature monitoring system
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161382, LVivo Software Application
Regular price $392.19 USDRegular priceUnit price / per -
FDA 510(k), K200232, LVivo Software Application
Regular price $620.32 USDRegular priceUnit price / per