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
39193–39216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 2014
ZOE FLUID STATUS MONITOR
K133301 · DSB
Noninvasive Medical Technologies, Inc.
Cardiovascular · 89d
Cleared Jan 22, 2014
REPROCESSED CLOSURE SYSTEM
K133414 · NLM
Sterilmed, Inc.
General & Plastic Surgery · 76d
Cleared Jan 22, 2014
VSP SYSTEM
K133907 · DZJ
Medical Modeling, Inc.
Dental · 30d
Cleared Jan 22, 2014
ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY
K133938 · GDW
Covidien
General & Plastic Surgery · 30d
Cleared Jan 22, 2014
ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)
K133950 · HTY
Bioretec, Ltd.
Orthopedic · 30d
Cleared Jan 22, 2014
LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL
K133960 · JJY
Bio-Rad Laboratories
Chemistry · 29d
Cleared Jan 21, 2014
A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM
K132125 · DZE
A.B. Dental Devices , Ltd.
Dental · 195d
Cleared Jan 21, 2014
ICRCO CLARITY VIEWER
K132499 · LLZ
Icrco, Inc.
Radiology · 165d
Cleared Jan 21, 2014
MOTION WATCH AND PRO-DIARY
K132764 · LEL
Camntech, Ltd.
Neurology · 139d
Cleared Jan 17, 2014
GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE...
K123517 · NBW
Sd Biosensor
Chemistry · 429d
Cleared Jan 17, 2014
BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS
K130614 · HRS
Laura Cattabriga
Orthopedic · 316d
Cleared Jan 17, 2014
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
K131168 · DJG
Immunalysis Corporation
Toxicology · 268d
Cleared Jan 17, 2014
OREGON SCINTIFIC
K131245 · DXN
Idt Technology Limited
Cardiovascular · 261d
Cleared Jan 17, 2014
SMARTDOP XT
K131623 · JOP
Koven Technology, Inc.
Cardiovascular · 227d
Cleared Jan 17, 2014
INJECTION NEEDLE
K132065 · FBK
Endochoice, Inc.
Gastroenterology & Urology · 198d
Cleared Jan 17, 2014
DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W
K132410 · JAK
Ge Medical Systems, LLC
Radiology · 168d
Cleared Jan 17, 2014
IOB DISPOSABLE SPECULUM
K132668 · HIB
Iob Medical, Inc.
Obstetrics & Gynecology · 143d
Cleared Jan 17, 2014
PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY...
K132682 · MCW
Atheromed, Inc.
Cardiovascular · 142d
Cleared Jan 17, 2014
SUPRAPUBIC CATHETER AND INTRODUCER SET
K132890 · KOB
Mediplus , Ltd.
Gastroenterology & Urology · 123d
Cleared Jan 17, 2014
GALAXY PLUS
K132921 · MQB
Medien International Co, Ltd.
Radiology · 122d
Cleared Jan 17, 2014
APOLLO SYSTEM
K132931 · GWG
Penumbra, Inc.
Neurology · 121d
Cleared Jan 17, 2014
FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE
K133197 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 92d
Cleared Jan 17, 2014
ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM
K133228 · LPH
Iconacy Orthopedic Implants, LLC
Orthopedic · 88d
Cleared Jan 17, 2014
XARIO 100
K133277 · IYN
Toshibamedical Systems Corporation
Radiology · 85d