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), K183685, System, Nuclear Magnetic Resonance Imaging
Regular price $1,201.75 USDRegular priceUnit price / per -
FDA 510(k), K843263, ARROW-JOHANS ECG ADAPTOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K845018, DAVOL ERCP CANNULA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K845036, TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K852069, MECTA ECT DEVICE MODELS SR & JR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K851422, S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K861316, DISPOSABLE NEEDLE COUNTER (20-240)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K861307, DISPOSABLE NEEDLE COUNTER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K854903, GORDON DIAGNOSTIC SYSTEM MODEL I
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K860467, ELECTROSHOCK UNIT NEUROLOGY MODEL B-25
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K864224, ABBOTT SPECTRUM GLUCOSE REAGENT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K864218, PROCON
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K864492, SWANSON TITANIUM GREAT TOE IMPLANT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K863815, ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K872018, KOTEX STICK TAMPONS, REGULAR AND SUPER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K872849, SPERM-SELECT ADDITIONAL INDICATION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K871242, REVERSE OSMOSIS WATER PURIFICATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K881577, MODIFIED SELECTIVE STREPTOCOCCUS AGAR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K881609, SITZMARKS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K883414, LARYNGOSCOPE BLADES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K883665, COONRAD III TOTAL ELBOW
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K881765, CTS-3060 AUTOMATED SEMEN ANALYZER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K890749, CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K893396, AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K892364, KALTOSTAT(TM) WOUND DRESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K884709, ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K895766, ASNIS II GUIDED BONE SCREW
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K894949, SQA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K895640, MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K900129, MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K896422, BURRON AMBULATORY DRUG DELIVERY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K900770, HOME URODATA SYSTEM(TM)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K901449, VACUTAINER PLUS WITH HEMOGARD CLOSURE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K902954, OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K903390, MEDRAD MARK V-PLUS INJECTOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K903654, LISS CRANIAL STIMULATOR MODEL SBL202-B
Regular price $149.00 USDRegular priceUnit price / per