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), K063166, I.T.S. PELVIC RECONSTRUCTION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062907, ALEXIS WOUND RETRACTOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062176, RELIEF ACP ORAL CARE GEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062998, COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062849, SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063530, ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062368, WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063626, DURAFLEX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063704, BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062789, SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063712, AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K053342, GENGIGEL MOUTHRINSE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K070173, VERTE-STACK SPINAL SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063844, REPROCESSED HEART STABILIZERS AND POSITIONERS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K070420, BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K070108, ELIBRA DYNAMIC KNEE BALANCER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K070220, OSTEOFIX BONE VOID FILLER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063503, OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071092, ASNIS MICRO CANNULATED SCREW
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071249, ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063876, MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071473, MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071354, MEPILEX AG DRESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071530, KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071920, AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072397, SYNOSS SYNTHETIC BONE GRAFT MATERIAL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072343, NEUROVISION JJB SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072983, SATURN 9000-750
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071535, BIOLOX DELTA CERAMIC FEMORAL HEAD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071371, COPA AMD ANTIMICROBIAL WOUND DRESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K073102, BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071202, DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072776, THE CROSSER SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072684, MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072870, MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080295, CHARLOTTE CLAW 3.5
Regular price $149.00 USDRegular priceUnit price / per