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
39697–39720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2013
GLB BENECHECK PREMIUM GLU MONITORING SYSTEM
K123090 · NBW
General Life Biotechnology Co., Ltd.
Chemistry · 417d
Cleared Nov 22, 2013
CLARITY LPC LASER SYSTEM
K130199 · GEX
Lutronic Corporation
General & Plastic Surgery · 298d
Cleared Nov 22, 2013
VIRTUOSO SYSTEM FOR IHC ER (SPI)
K130515 · NQN
Ventana Medical Systems, Inc.
Pathology · 268d
Cleared Nov 22, 2013
REDSENSE ALARM SYSTEM
K130554 · ODX
Redsense Medical AB
Gastroenterology & Urology · 263d
Cleared Nov 22, 2013
V-STICK VASCULAR ACCESS SET
K130730 · DYB
Argon Medical
Cardiovascular · 249d
Cleared Nov 22, 2013
SOFIA DISTAL ACCESS CATHETER
K131482 · DQY
MicroVention, Inc.
Cardiovascular · 183d
Cleared Nov 22, 2013
PC ECG
K131819 · DPS
Edan Instruments, Inc.
Cardiovascular · 155d
Cleared Nov 22, 2013
TOPTOUCH /OTHER CLIENTS PRIVATE LABELING
K131826 · LYZ
Jiangsu Toptouch Glove Co., Ltd.
General Hospital · 155d
Cleared Nov 22, 2013
MAGNETOM PRISMA, MAGNETOM PRISMA FIT
K132119 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 136d
Cleared Nov 22, 2013
OTOMAG BONE CONDUCATION HEARING SYSTEM
K132189 · LXB
Sophono, Inc.
Ear, Nose, Throat · 130d
Cleared Nov 22, 2013
SP-FIX SPINOUS PROCESS FIXATION PLATE
K132191 · PEK
Globus Medical, Inc.
Orthopedic · 130d
Cleared Nov 22, 2013
CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE...
K132288 · NBW
I-Sens, Inc.
Chemistry · 122d
Cleared Nov 22, 2013
EASYCARE ONLINE
K132371 · MNS
Resmed, Ltd.
Anesthesiology · 115d
Cleared Nov 22, 2013
PIEZON 150
K132443 · ELC
E.M.S Electro Medical Systems S.A
Dental · 108d
Cleared Nov 22, 2013
ADHESIVE ELECTRODES
K132588 · GXY
Top-Rank Health Care Equipment Co., Ltd.
Neurology · 95d
Cleared Nov 22, 2013
V8 TRANSLUMINAL BAV CATHETER
K132728 · OZT
Intervalve, Inc.
Cardiovascular · 80d
Cleared Nov 22, 2013
SENSE-4BABY SYSTEM
K132918 · HGM
Sense4baby , Inc.
Obstetrics & Gynecology · 66d
Cleared Nov 22, 2013
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
K133067 · CDT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared Nov 22, 2013
CRESCENT SPINAL SYSTEM
K133216 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 35d
Cleared Nov 22, 2013
ELECSYS CK-MB CALCHECK 5
K133284 · JJX
Roche Diagnostics
Chemistry · 28d
Cleared Nov 22, 2013
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
K133399 · MCW
Cardiovascular Systems Incorporated
Cardiovascular · 16d
Cleared Nov 21, 2013
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
K123977 · CGS
Randox Laboratories, Ltd.
Chemistry · 330d
Cleared Nov 21, 2013
AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO,...
K130514 · KLW
Audifon-USA, Inc.
Ear, Nose, Throat · 267d
Cleared Nov 21, 2013
MALDI BIOTYPER CA (MBT-CA) SYSTEM
K130831 · PEX
Bruker Daltonics, Inc.
Microbiology · 240d