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), K012767, S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K992760, SELECT-SUTTER MICRO BIPOLAR FORCEPS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K883780, XTREL, MODEL NUMBER 3425
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K934065, MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K102871, SILVER CARE ANITBACTERIAL TOOTHBRUSH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K043341, BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042992, CORAIL AMT HIP PROSTHESIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K043272, PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111372, TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K034052, BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K022548, MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K014087, LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K023811, MODIFICATION TO VIABAHN ENDOPROSTHESIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K013648, VIABAHN ENDOPROSTHESIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142458, Penumbra System ACE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K162176, Fiagon Navigation System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130874, STRYKER NAV3I PLATFORM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K900759, POLY-OP (TM)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030625, SPINAL CONCEPTS INC. PATHFINDER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002177, THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132567, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K102966, 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160538, Sysmex XN-L Automated Hematology Analyzer
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K854740, PRIMADERM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K820339, ISLAM BONE MARROW BIOPSY NEEDLE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062779, DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K073116, EBI INTERNAL IMPLANT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083594, EZ HSG CATHETER.FOAMSEAL CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K012105, POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K032119, PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K964599, TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K964598, TRUSTEX COLA FLAVORD CONDOM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K970633, TUSTEX FLAVORED CONDOMS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K924724, KINETIK GREAT TOE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K935947, HI-TOPS ELECTRODES 14-8000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K971320, CRE BALLOON DILATATION CATHETER
Regular price $149.00 USDRegular priceUnit price / per