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
37945–37968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 2014
FEIYUE
K140242 · LYZ
Feiyue Glove Co., Ltd.
General Hospital · 133d
Cleared Jun 12, 2014
WARTIE WART REMOVER
K140314 · GEH
Yonmedical BV
General & Plastic Surgery · 122d
Cleared Jun 12, 2014
WHITE VINYL EXAM GLOVES POWDER FREE
K140322 · LYZ
Shandong Dawei Medical Products Co.,...
General Hospital · 122d
Cleared Jun 12, 2014
META-C CERVICAL PLATE
K140361 · KWQ
Medacta International
Orthopedic · 120d
Cleared Jun 12, 2014
COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE,...
K140695 · DQX
Medtronic, Inc.
Cardiovascular · 85d
Cleared Jun 12, 2014
VIAL2BAG DIRECT CONNECT
K140730 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 80d
Cleared Jun 12, 2014
AFFINITY PIXIE OXYGENATION SYSTEM WITH
K141233 · DTN
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jun 12, 2014
TEVADAPTOR
K141306 · FPA
Teva Medical Ltd., Migada Plant
General Hospital · 24d
Cleared Jun 12, 2014
TRIPLEPLAY PRO
K141360 · JOW
Wildcat Medical, Inc.
Cardiovascular · 20d
Cleared Jun 12, 2014
DURADIAGNOST
K141381 · KPR
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 16d
Cleared Jun 11, 2014
DIGITAL ELECTROCARDIOGRAPH
K131858 · DPS
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 352d
Cleared Jun 11, 2014
JO PREMIUM PERSONAL LUBRICANT
K132954 · NUC
United Consortium
Obstetrics & Gynecology · 264d
Cleared CT Jun 11, 2014
OPTICAL BIOMETER AL-SCAN
K133132 · HJO
Nidek Co., Ltd.
Ophthalmic · 254d
Cleared Jun 11, 2014
FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT...
K133403 · LPL
Firestone Optics, Inc.
Ophthalmic · 217d
Cleared Jun 11, 2014
BASE IT
K134022 · EJK
Spident Co., Ltd.
Dental · 163d
Cleared Jun 11, 2014
CONTRAST MODULATION SYSTEM
K140425 · DXT
Osprey Medical, Inc.
Cardiovascular · 112d
Cleared Jun 11, 2014
CELESTEION, PCA-9000A/2
K140651 · KPS
Toshibamedical Systems Corporation
Radiology · 90d
Cleared Jun 11, 2014
FLEX ENDOSCOPIC INSTRUMENTS
K140662 · GCJ
Design Standards Corp.
General & Plastic Surgery · 89d
Cleared Jun 11, 2014
INTRA-OPERATIVE ULTRASOUND TRANSDUCER
K140854 · ITX
Hitachi Aloka Medical, Ltd.
Radiology · 69d
Cleared Jun 11, 2014
MTA2.1 MATERIAL
K140955 · KIF
Avalon Biomed, Inc.
Dental · 58d
Cleared Jun 11, 2014
MAMMI
K140996 · KPS
General Equipment For Medical Imaging...
Radiology · 55d
Cleared Jun 11, 2014
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K141250 · FGB
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 28d
Cleared Jun 10, 2014
SPIROX INEX DEVICE
K132920 · NHB
Spirox, Inc.
Ear, Nose, Throat · 266d
Cleared Jun 10, 2014
QUADROSTARPROGREEN, QUADROSTARPROYELLOW
K133297 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 228d