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), K033671, GORE BIOABSORBABLE MESH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K033769, EIUS UNICOMPARTMENTAL KNEE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K032350, INFRARED SCIENCES BREASTSCAN IR SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K033820, MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040183, BISX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K033981, SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040405, CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K033967, TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040073, SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K033998, MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K033485, ENDOSCOUT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040067, CLIRPATH EXCIMER LASER CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040981, USW NEEDLEKNIFE PAPILLOTOME
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040389, COONRAD/MORREY ELBOW CEMENT RESTRICTOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040512, LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040911, VITALHEAT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040416, SONICARE ADVANCE TOOTHBRUSH, MODEL 4900
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K033448, ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K041148, POCONE INFRARED SPECTROPHOTOMETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040554, ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K041338, MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K041263, NEUROGUIDE ANALYSIS SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K041194, ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040490, WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K041889, TRI-OSTETIC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K041493, CEMENTEK
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K041528, MODIFICATION TO EPTFE GRAFT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042616, BIOMEDIX PADNET LAB
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042501, ETG-4000 OPTICAL TOPOGRAPHY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K041934, 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040839, COMPLETE BLINK-N-CLEAN LENS DROPS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042750, QC-BEADS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040021, SHUNTCHECK (PROMETHEUS 1)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042231, GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042889, DYNAMOMETER - MODEL FCE AND MODEL MSC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042076, FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5
Regular price $149.00 USDRegular priceUnit price / per