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), K123909, AESCULAP CESPACE XP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120250, FIBRILLAR COLLAGEN WOUND DRESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130899, BIOLOX DELTA CERAMIC FEMORAL HEADS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123542, PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130077, REMSTAR SE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130524, BREATHID HP SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130288, STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123481, AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130446, FASTBRACES CERAMIC BRACKETS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130185, 4WEB OSTEOTOMY BONE WEDGE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130025, SONENDO ENDOTHERAPY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121214, ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131153, EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131131, E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123427, NIRVANA D PERSONAL LUBRICANT (TBD)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131283, PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123881, HEARTSINE SAMARITAN PAD 350P
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131434, VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131203, IHEALTH CLOUD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130702, AIRSONETT AIR-4
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130126, SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122337, OVUSENSE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130887, S4C NAVIGATION INSTRUMENTS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131197, EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K124044, ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130341, STRAWBERRY, STRAWBERRY & CREAM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131122, S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132317, MICROPLEX COIL SYSTEM (MCS), VFC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132667, SYNERGY ODM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131684, BIOLOX(R) DELTA CERAMIC HEADS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132560, PCP-USB STETHOSCOPE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131337, BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131991, ENDOCHOICE HOT BIOPSY FORCEPS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K124041, NBM-200MP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130357, SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122061, K-Y BRAND LIQUIBEADS
Regular price $149.00 USDRegular priceUnit price / per