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
48529–48552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2011
ISCREEN VISION SCREENER
K102651 · HKI
Iscreen Vision, Inc.
Ophthalmic · 120d
Cleared Jan 12, 2011
ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)
K102834 · JDQ
Kinamed, Incorporated
Orthopedic · 105d
Cleared Jan 12, 2011
OSBONE DENTAL
K102872 · LYC
Curasan AG
Dental · 104d
Cleared Jan 12, 2011
VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM
K102915 · MUJ
Viewray, Incorporated
Radiology · 103d
Cleared Jan 12, 2011
GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +
K103070 · KWQ
G Surgical Co., Ltd.
Orthopedic · 86d
Cleared Jan 12, 2011
DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM
K103144 · IYN
Shantou Institute of Ultrasonic...
Radiology · 79d
Cleared Jan 12, 2011
DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR)
K103365 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 56d
Cleared Jan 12, 2011
BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)
K103394 · IYE
Varian Medical Systems, Oncology Systems
Radiology · 54d
Cleared Jan 12, 2011
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM
K103645 · ITX
Toshiba Medical Systems Corporation,...
Radiology · 30d
Cleared Jan 12, 2011
EXPECT ENDOSCOPIC ASPIRATION NEEDLE
K110030 · ODG
Boston Scientific Corp
Gastroenterology & Urology · 7d
Cleared Jan 11, 2011
EMBRYOSCOPE AND EMBRYOSLIDE
K092183 · MQG
Unisense Fertilitech A/S
Obstetrics & Gynecology · 539d
Cleared Jan 11, 2011
BT-CATH
K101535 · OQY
Utah Medical Products, Inc.
Obstetrics & Gynecology · 222d
Cleared Jan 11, 2011
HVR PAIN RELIEF DEVICE
K101716 · ILY
H.V.R., Inc.
Physical Medicine · 207d
Cleared Jan 11, 2011
CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD
K101995 · DQA
Oridion Capnography, Inc.
Anesthesiology · 181d
Cleared Jan 11, 2011
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE...
K102781 · FAS
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 106d
Cleared Jan 11, 2011
CARDIO MED MODEL A102, H104, O101, P103, AND Z100
K103159 · LDD
Cardio Medical Products, Inc.
Cardiovascular · 77d
Cleared Jan 11, 2011
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
K103275 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 67d
Cleared Jan 11, 2011
PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER
K103470 · GDW
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT...
General & Plastic Surgery · 46d
Cleared Jan 10, 2011
YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02
K102508 · FLL
Yu Long Sheng Technology Co., Ltd.
General Hospital · 131d
Cleared Jan 10, 2011
AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
K102617 · JJY
Aalto Scientific, Ltd.
Chemistry · 122d
Cleared Jan 10, 2011
IMPLANT-ONE SYSTEM
K102822 · DZE
Custom Dental Implants, Inc.
Dental · 104d
Cleared Jan 10, 2011
TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX
K103033 · ODP
Zimmer Trabecular Metal Technology
Orthopedic · 89d
Cleared Jan 10, 2011
ALLOFUSE PLUS
K103036 · MQV
Allosource, Inc.
Orthopedic · 89d
Cleared Jan 10, 2011
HOSMAN USB BLOOD PRESSURE MONITOR
K103046 · DXN
Hosman International Co., Ltd.
Cardiovascular · 88d