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), K040238, SOFTSEAL HSG CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K012990, COLLATEK POWDER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K012995, COLLATEK SHEET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K012997, COLLATEK FOAM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K010309, SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101194, NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151413, Always/Tampax bladder supports
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K952737, CALVITRON HAIR TRANSPLANT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080202, ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K102329, NANOKNIFE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150089, NanoKnife System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120737, TRIA LASER HAIR REMOVAL SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K053527, SPECTRA HAIR REMOVAL LASER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052848, SPECTRA HAIR REMOVAL LASER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K993157, HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K982941, HEM-O-LOK MODEL NUMBERS 523900, 523970
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K922186, HEM-O-LOK -- MODIFICATION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082481, FLOWPICC CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K081626, FLOWPICC CONSOLE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K081625, FLOWPICC STYLET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K073166, ENDOWAVE INFUSION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141617, CLEANER ROTATIONAL THROMBECTOMY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K921891, SILENT SCAN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111705, EKOSONIC ENDOVASCULAR SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K031875, INTER-OS LIMB LENGTHENER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051162, GENEROS SB SMALL BONE DISTRACTION IMPLANT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K990170, HOLTER 2000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K983102, CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K103825, V-GO INSULIN DELIVERY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111210, T:SLIM (TM) INSULIN DELIVERY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092086, AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K053476, ALLWOUND
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K854593, NORFOLK MEDICAL PERITONEAL-ACCESS PORT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161631, MAMMI
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K993120, MODIFIED BLOOD RECIPIENT SET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061855, NEUROQUANT
Regular price $149.00 USDRegular priceUnit price / per