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
53353–53376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2009
PELVIC FLOOR REPAIR SYSTEM
K091131 · OTP
Boston Scientific
Obstetrics & Gynecology · 18d
Cleared May 08, 2009
GRIND NO MORE VERSION 2 AND 3
K091175 · OBR
Ranir, LLC
Dental · 16d
Cleared May 08, 2009
MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM
K091257 · FCG
Medi-Globe Corporation
Gastroenterology & Urology · 9d
Cleared May 08, 2009
NEUROPET
K091269 · KPS
Photodetection Systems, Inc.
Radiology · 8d
Cleared May 07, 2009
SAFEFLO VENA CAVA FILTER
K081138 · DTK
Rmt Medical Technilogies, Inc.
Cardiovascular · 381d
Cleared May 07, 2009
CIRCULATOR BOOT
K082134 · DRN
Circulator Boot Corp.
Cardiovascular · 282d
Cleared May 07, 2009
INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT
K082497 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 251d
Cleared May 07, 2009
ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC
K082834 · GEI
Ellman Int'L, Inc.
General & Plastic Surgery · 223d
Cleared May 07, 2009
PROCERA IMPLANT BRIDGE OVERDENTURE
K090069 · NHA
Nobel Biocare AB
Dental · 115d
Cleared May 07, 2009
HANSEN MEDICAL ARTISAN S CONTROL CATHETER
K090365 · DXX
Hansen Medical, Inc.
Cardiovascular · 83d
Cleared May 07, 2009
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC
K090428 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 77d
Cleared May 07, 2009
SPEQ ULTRASOUND SYSTEM
K090505 · IYO
Signostics Pty, Ltd.
Radiology · 70d
Cleared May 07, 2009
INNOPORT LAPAROSCOPIC ACCESS DEVICE
K090677 · GCJ
Innovia, LLC
General & Plastic Surgery · 52d
Cleared May 07, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K090691 · LYZ
Shijiazhuang Benestar Plastic Co., Ltd.
General Hospital · 52d
Cleared May 07, 2009
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020
K091152 · OTM
Coloplast A/S
Gastroenterology & Urology · 17d
Cleared May 06, 2009
PATHFAST D-DIMER
K072288 · GHH
Mitsubishi Kagaku Iatron
Hematology · 629d
Cleared May 06, 2009
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
K081640 · HCH
Gimmi GmbH
Neurology · 329d
Cleared May 06, 2009
HUMAN BETA-2 MICROGLOBULIN KIT
K083289 · JZG
The Binding Site, Ltd.
Immunology · 180d
Cleared May 06, 2009
LASER TOUCHONE
K083822 · GZJ
Laser Health Technologies, LLC
Neurology · 135d
Cleared May 06, 2009
MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00
K083922 · DQO
Micrus Endovascular Corporation
Cardiovascular · 126d
Cleared May 06, 2009
MODIFICATION TO: PSS SYSTEM
K090033 · MNI
Spinal USA
Orthopedic · 120d
Cleared May 06, 2009
PAINMASTER MCT PATCH
K090042 · NUH
Newmark, Inc.
Neurology · 120d
Cleared May 06, 2009
MATCHEDFLICKER
K090266 · NFJ
Eyeic Corporation
Ophthalmic · 92d
Cleared May 06, 2009
HD GUIDE CATHETER
K090335 · DQY
Concentric Medical, Inc.
Cardiovascular · 85d