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
36193–36216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 24, 2014
Straight Stud Attachment
K142407 · NHA
Sterngold Dental, LLC
Dental · 118d
Cleared Dec 24, 2014
CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT...
K142429 · HCG
Codman & Shurtleff, Inc.
Neurology · 117d
Cleared Dec 24, 2014
IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000...
K143352 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 30d
Cleared Dec 23, 2014
Burn Resuscitation Decision Support System - Clinical (BRDSS-C)
K140387 · PDT
The Surgeon General, Department of...
General & Plastic Surgery · 312d
Cleared Dec 23, 2014
ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT...
K140436 · OSX
Fujirebio Diagnostics,Inc.
Chemistry · 305d
Cleared Dec 23, 2014
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
K141479 · LZH
Covidien
General Hospital · 202d
Cleared Dec 23, 2014
Wrist Hemiarthroplasty System
K141920 · KWN
Arthrosurface, Inc.
Orthopedic · 160d
Cleared Dec 23, 2014
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K142151 · JWY
Thermo Fisher Scientific
Microbiology · 139d
Cleared Dec 23, 2014
HP Tissue Matrix
K142326 · FTM
Lifecell Corporation
General & Plastic Surgery · 125d
Cleared Dec 23, 2014
nvc
K142328 · ODP
Nvision Biomedical Technologies, LLC
Orthopedic · 125d
Cleared Dec 23, 2014
TISSUE CONTAINMENT SYSTEM
K142427 · GCJ
Applied Medical Resources
General & Plastic Surgery · 116d
Cleared Dec 23, 2014
ALIANS ULNA LOCKING PLATING SYSTEM
K142502 · HRS
Newclip Technics
Orthopedic · 109d
Cleared Dec 23, 2014
JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis...
K142564 · FIE
JMS North America Corporation
Gastroenterology & Urology · 103d
Cleared Dec 23, 2014
Instru-Safe Instrument Protection System
K142630 · KCT
Summit Medical, Inc.
General Hospital · 97d
Cleared Dec 23, 2014
NExCT 7
K142697 · JAK
Neurologica Corporation
Radiology · 92d
Cleared Dec 23, 2014
Biomet Tibial trays
K142933 · JWH
Biomet, Inc.
Orthopedic · 75d
Cleared Dec 23, 2014
Nice1
K143197 · IRP
Nice Recovery Systems, LLC
Physical Medicine · 47d
Cleared Dec 23, 2014
ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur...
K143376 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 28d
Cleared Dec 23, 2014
Klassic HD Hip System
K143407 · LZO
Total Joint Othopedics, Inc.
Orthopedic · 25d
Cleared Dec 22, 2014
SPEEDY FLAP SYSTEM
K130447 · GXN
Jeil Medical Corporation
Neurology · 669d
Cleared Dec 22, 2014
EVOTECH ECR
K140977 · FEB
Advanced Sterilization Products
General Hospital · 250d
Cleared Dec 22, 2014
POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE)
K140989 · KGO
Hebei Hongsen Plastics Technology Co,...
General Hospital · 249d
Cleared Dec 22, 2014
BOVINE PERICARDIUM PATCH
K141721 · FTM
Collafirm, LLC
General & Plastic Surgery · 180d
Cleared Dec 22, 2014
Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access...
K142373 · MRG
Beckman Coulter, Inc.
Chemistry · 119d