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
40945–40968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 2013
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE
K131181 · LCM
Omega Laboratories, Inc.
Toxicology · 61d
Cleared Jun 25, 2013
DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
K131314 · MQB
Swissray Medical AG
Radiology · 49d
Cleared Jun 25, 2013
SHANGRING
K131373 · HFX
Wuhu Snnda Medical Treatment...
Obstetrics & Gynecology · 43d
Cleared Jun 25, 2013
TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION
K131489 · IYO
Tractus Corporation
Radiology · 33d
Cleared Jun 24, 2013
LAWMAX DILATOR
K123842 · DRE
Lifetech Scientific (Shenzhen) Co., Ltd.
Cardiovascular · 193d
Cleared Jun 24, 2013
STEALTH 360 ORBITAL PAD SYSTEM
K131092 · MCW
Cardio Systems, Inc.
Cardiovascular · 67d
Cleared Jun 24, 2013
CARDIOSLEEVE
K131287 · DQD
Rijuven Corp
Cardiovascular · 49d
Cleared Jun 23, 2013
PROTEUS PATCH INCLUDING INGESTIBLE SENSOR
K131524 · OZW
Proteus Digital Health, Inc.
Gastroenterology & Urology · 26d
Cleared Jun 21, 2013
MFM-CMS CENTRAL MONITORING SYSTEM
K120727 · MHX
Edan Instruments, Inc.
Cardiovascular · 469d
Cleared Jun 21, 2013
TEZO TITANIUM CAGE FAMILY
K122957 · MAX
Ulrich GmbH & Co. KG
Orthopedic · 269d
Cleared Jun 21, 2013
ION MAGNUM GENIUS
K123158 · NGX
Ion Genius, Inc.
Physical Medicine · 255d
Cleared Jun 21, 2013
BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS)
K124038 · MWI
Bedside Clinical Systems, Inc.
Cardiovascular · 175d
Cleared Jun 21, 2013
TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
K130099 · LPH
Encore Medical, L.P.
Orthopedic · 157d
Cleared Jun 21, 2013
OAK RIDGE PRODUCTS SHARP CONTAINER
K130281 · MMK
Oak Ridge Products, LLC
General Hospital · 136d
Cleared Jun 21, 2013
LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL...
K130295 · NBW
Infopia Co, Ltd.
Chemistry · 135d
Cleared Jun 21, 2013
CERTAIN BELLATEK PROVISIONAL ABUTMENTS
K130310 · NHA
Biomet 3i
Dental · 134d
Cleared Jun 21, 2013
HYRDROMAX HMEF
K130664 · CAH
A-M Systems
General Hospital · 101d
Cleared Jun 21, 2013
INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)
K130816 · GXY
Neuro Resource Group, Inc.
Neurology · 88d
Cleared Jun 21, 2013
DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K130833 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 87d
Cleared Jun 21, 2013
FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
K130914 · PEN
Biofire Diagnostics, Inc.
Microbiology · 80d
Cleared Jun 21, 2013
E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM
K131131 · EOX
Intromedic Co., Ltd.
Ear, Nose, Throat · 60d
Cleared Jun 21, 2013
DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K131213 · IYN
Sonoscape Company Limited
Radiology · 53d
Cleared Jun 21, 2013
VERRATA PRESSURE GUIDE WIRE
K131288 · DQX
Volcano Corporation
Cardiovascular · 46d
Cleared Jun 20, 2013
AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
K112598 · HBA
American Surgical Company, LLC
Neurology · 652d