Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
42001–42024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2013
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE
K130038 · LZA
Hl Rubber Industries Sdn Bhd
General Hospital · 45d
Cleared Feb 20, 2013
MDU5 PLUS STERILE BAG
K123424 · ITX
Boston Scientific Corp
Radiology · 105d
Cleared Feb 20, 2013
TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
K123425 · MBI
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Feb 20, 2013
SYNSPAR ADVANCED
K123613 · EIH
Ardent, Inc.
Dental · 89d
Cleared Feb 20, 2013
ARIX RAD ACQUISITION CONSOLE
K123650 · LLZ
Compania Mexicana DE Radiologia Cgr,...
Radiology · 85d
Cleared Feb 19, 2013
REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200
K110941 · GEX
Allmed Systems, Inc.
General & Plastic Surgery · 687d
Cleared Feb 19, 2013
COMMUNIFY PACS VIEWER
K120851 · LLZ
Communify Health, LLC
Radiology · 335d
Cleared Feb 19, 2013
DESARA SL
K121928 · OTN
Caldera Medical, Inc.
Gastroenterology & Urology · 232d
Cleared Feb 19, 2013
LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT
K122477 · NUC
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 189d
Cleared CT Feb 19, 2013
ARTAS SYSTEM FROM RESTORATION ROBOTICS
K123154 · ONA
Restoration Robotics, Inc.
General & Plastic Surgery · 133d
Cleared Feb 19, 2013
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED,...
K123469 · LZA
Wear Safe (Malaysia) Sdn Bhd -...
General Hospital · 98d
Cleared Feb 19, 2013
MAMMOWORKSTATION
K123575 · LLZ
Image Diagnost International GmbH
Radiology · 91d
Cleared Feb 19, 2013
INTRADERMAL ADAPTER
K123588 · FMF
West Pharmaceutical Services, Inc.
General Hospital · 90d
Cleared Feb 19, 2013
NEXUS RMGI
K123595 · EMA
Kerr Corporation
Dental · 90d
Cleared Feb 15, 2013
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN...
K121608 · MRG
Ortho-Clinical Diagnostics, Inc.
Chemistry · 259d
Cleared Feb 15, 2013
ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH...
K122177 · JIT
Elitechgroup
Chemistry · 207d
Cleared Feb 15, 2013
FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS...
K122315 · LPL
Oculus Private Limited
Ophthalmic · 198d
Cleared Feb 15, 2013
SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA...
K122518 · ODP
Bm Korea Co., Ltd.
Orthopedic · 182d
Cleared Feb 15, 2013
TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND
K122710 · IYN
Shenzhen Delicate Electronics Co., Ltd.
Radiology · 164d
Cleared Feb 15, 2013
CPI RAD VISION
K122726 · KPR
Communications & Power Industries...
Radiology · 163d
Cleared Feb 15, 2013
GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN,...
K122894 · NPM
Geistlich Pharma AG
Dental · 148d
Cleared Feb 15, 2013
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
K123164 · MNH
Spinefrontier, Inc.
Orthopedic · 129d
Cleared Feb 15, 2013
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
K123320 · JIF
Siemens Healthcare Diagnostics
Chemistry · 112d
Cleared Feb 15, 2013
DIMENSION CHEMISTRY III CALIBRATORY
K123321 · JIX
Siemens Healthcare Diagnostics
Chemistry · 112d