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), K132272, GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130886, GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122142, GLOOKO LOGBOOK CHARTS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141953, ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153513, Insufflator 50L FM134
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113514, SMARTHEART
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150564, Spaulding Electrocardiograph 2100iQ
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152923, BD ChloraShield IV Dressing with CHG Antimicrobial
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140133, INFUSET FLOW CONTROL EXTENSION SET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151163, Signia Loading Unit, Tri-Staple 2.0 Cartridge
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150682, CUSA Excel+
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133589, SOMATOM FORCE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133507, GUIDOSS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050446, BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150841, Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072522, THERMOFORM SHEET MATERIALS AND ACCESSORIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132535, AUTOBAND LIGATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153466, PillCam COLON 2 Capsule Endoscopy System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132447, VITALCONNECT PLATFORM BY VITAL CONNECT INC.
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111516, NMR LIPOPROFILE (R) TEST AND NMR PROFILER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113830, VANTERA CLINICAL ANALYZER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133849, VANTERA CLINICAL ANALYZER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091703, HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151532, KYPHON ELEMENT Inflatable Bone Tamp
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K070015, COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091608, COBALT MV BONE CEMENT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K830228, OTOLOGICAL VENTILATION TUBES-VARIOUS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K812460, VARIOUS AURAL GROMMETS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K810701, EXMOOR AURAL GROMMET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K883969, UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130132, BABYLANCE HEEL INCISION DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141827, EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100574, COLLEXA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K984361, ORAL-EZE ORAL FLUID COLLECTION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141474, BECTON DICKINSON INTELLIPORT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142648, SPINEDESIGN Spine Surgery Planning (Software Application)
Regular price $149.00 USDRegular priceUnit price / per