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), K080217, COMPONENT NEUROMONITORING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040723, MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153331, SafeCT-29
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122494, POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161640, Penumbra System ACE 68 Reperfusion Catheter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160449, Penumbra System, Penumbra Pump MAX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151623, Penumbra System 110 Aspiration Tubing
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100371, SPY INTRA-OPERATIVE IMAGING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130793, NEWA SKIN THERAPY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K954167, HUMPHREY FIELD ANALYZER (HFA II)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143643, Brainscope Ahead 200
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140497, ECVUE MAPPING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141830, STIMULAN KIT, STIMULAN RAPID CURE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142245, EpiAccess System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K021501, V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091585, VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100657, V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090160, SUPRATHEL WOUND AND BURN DRESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092117, SCENAR, MODEL 10
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132940, ERCHONIA ALLAY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083822, LASER TOUCHONE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130996, ERCHONIA EMERGE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100116, LASERTOUCHONE (OTC)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143677, DeVilbiss Intellipap2/DeVilbiss BLUE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150111, Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150572, Respire Pink Series-Herbst-EF
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092713, SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092981, PANPAC VAGINAL PESSARY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132313, PESSARY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150639, AF541 EE Full Face Mask
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150638, AF541 SE Full Face Mask
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141943, BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143700, CPAP Cannulaide
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130857, PRONTOSAN WOUND GEL X
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143196, syngo.CT Lung CAD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K070326, NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per