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
47449–47472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 2011
IQ VENTILATION NASAL MASK
K102317 · BZD
Sleepnet Corporation
Anesthesiology · 274d
Cleared May 17, 2011
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR
K103094 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 210d
Cleared May 17, 2011
MAC 600 RESTING ECG ANALYSIS SYSTEM
K103765 · DPS
Ge Medical Systems Information...
Cardiovascular · 145d
Cleared May 17, 2011
DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
K110188 · LCP
Diazyme Laboratories
Chemistry · 113d
Cleared May 17, 2011
SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL
K110484 · EBG
Novocol, Inc.
Dental · 88d
Cleared May 17, 2011
EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
K110706 · KWT
Exactech, Inc.
Orthopedic · 64d
Cleared CT May 17, 2011
RPS ADENO DETECTOR PLUS
K110722 · GOD
Rapid Pathogen Screening, Inc.
Microbiology · 63d
Cleared May 17, 2011
STERILE STORM (R) OPERATING KIT
K111001 · HWC
Intelligent Orthopaedics, Ltd.
Orthopedic · 36d
Cleared May 17, 2011
CHITOGAUZE FUSION
K111163 · QSY
Hem Con Medical Technologies, Inc.
General & Plastic Surgery · 21d
Cleared May 17, 2011
REMOTE VIEW SOFTWARE
K111321 · NBL
Cariescan , Ltd.
Dental · 6d
Cleared May 16, 2011
PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2
K100130 · MMI
Mitsubishi Chemical Medience CO
Chemistry · 482d
Cleared May 16, 2011
CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
K101779 · KPR
Jpi Healthcare Co, Ltd.
Radiology · 325d
Cleared May 16, 2011
ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
K102535 · JWY
Biomerieux S.A.
Microbiology · 255d
Cleared May 16, 2011
ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510
K102887 · FFL
Percutaneous Systems, Inc.
Gastroenterology & Urology · 228d
Cleared May 16, 2011
STRATUS CS ACUTE CARE D-DIMER
K110303 · DAP
Siemens Healthcare Diagnostics
Hematology · 104d
Cleared May 16, 2011
SIGNATURE PLANNER / SIGNATURE GUIDES
K110415 · HRY
Materialise NV
Orthopedic · 91d
Cleared May 16, 2011
S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K110510 · IYN
Sonoscape Company Limited
Radiology · 83d
Cleared May 16, 2011
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
K110986 · HKI
Optomed OY
Ophthalmic · 38d
Cleared May 16, 2011
FUJINON ULTRASONIC PROCESSOR
K111243 · FDS
Fujinon, Inc.
Radiology · 13d
Cleared May 13, 2011
INVADER MTHFR 677
K100987 · OMM
Hologic, Inc.
Pathology · 399d
Cleared May 13, 2011
BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA
K102328 · FMI
Shandong Weigao Group Medical Polymer...
General Hospital · 269d
Cleared May 13, 2011
DIMENSIONS HB1C KIT, MODEL DF105A
K102510 · LCP
Siemens Healthcare Diagnostics
Chemistry · 259d
Cleared May 13, 2011
HI-DOW-XP
K102598 · NUH
Hi-Dow International, Inc.
Neurology · 245d
Cleared May 13, 2011
COMPUTED RADDIOGRAPHY SCANNER
K102619 · MQB
3Disc Americas
Radiology · 242d