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), K080271, INREACH SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K073690, INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080383, AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080118, ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080093, PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K073311, OSTEOTRANS-OT PIN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080631, CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063723, IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K081379, MODIFICATION TO INREACH SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080330, SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080180, MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072741, PRE-VA VAGINAL LUBRICANT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080252, MODIFICATION TO MAMMAPRINT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K081070, INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063841, NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072370, SURGICRAFT SURGICAL MESH SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080668, G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072629, DIGIMATCH ROBODOC SURGICAL SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K081942, NEUROCATH AG
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K081459, CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K081048, PINNACLE PELVIC FLOOR REPAIR KIT II
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080795, ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082386, INREACH PLANNING LAPTOP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080275, NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K081475, ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K081791, E-Z CLEAN ELECTROSURGICAL ELECTRODE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082870, VTI INTRAOPERATIVE DOPPLER SYSTEMS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082720, TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080613, CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080591, TANDA SKINCARE SYSTEM, MODEL: PTSCS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K081981, LANG DENTAL ACRYLIC PRIMER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082991, BIOLOX DELTA CERAMIC FEMORAL HEAD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082844, BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082423, NO!NO! SKIN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080595, CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082384, HAV-LOK BUNION CORRECTION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per