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), K111314, MORPHEUS OX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141518, Nellcor Bedside Respiratory Patient Monitoring System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150899, Straumann CARES Titanium Alloy (TAN) Abutment
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150245, CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131113, BIOPHOTAS CELLUMA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122237, BIOPHOTAS LIFELIGHT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K060814, DYNATRON ION IONTOPHORESIS ELECTRODE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133444, STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133573, FIAGON NAVIGATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141456, THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141769, OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133665, MALLEABLE SUCTION INSTRUMENTS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142774, Polysmith Sleep System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132749, NOBELPROCERA OVERDENTURE BAR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030379, APLAB, MODEL 801D0030
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K041662, APNEA RISK EVALUATION SYSTEM (ARES)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K010739, WATCH-PAT 100
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042694, ADVANCED LUNG ANALYSIS II
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143275, IOLMaster700
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123369, ILUMIEN OPTIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080444, CONMED LINVATEC OSPREY DRILL SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142672, AliveCor Heart Monitor
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130921, ALIVECOR HEART MONITOR OTC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123387, QUIKCLOT HEMOSTATIC DRESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142327, smARTrack Feeding Tube System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K060526, TIPI
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131198, TIPI OTC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132931, APOLLO SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100591, SORBACT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063059, SORBACT WOUND DRESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141952, ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130391, EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K103110, MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123279, MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093998, KNEEALIGN SYSTEM WITH REFERENCE SENSOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090474, ORTHOREX INTRA-OPERATIVE LOAD SENSOR
Regular price $149.00 USDRegular priceUnit price / per