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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
53617–53640 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 06, 2009
LARIAT II SUTURE DELIVERY DEVICE
K090385 · GAT
Sentreheart, Inc.
General & Plastic Surgery · 78d
Cleared May 06, 2009
ASTHMA MONITOR MODEL, AM1
K090486 · BZG
Cardinal Health Germany 234 GmbH
Anesthesiology · 70d
Cleared May 06, 2009
MIRAGE ECHO
K090490 · BZD
ResMed Corp
Anesthesiology · 70d
Cleared May 06, 2009
PARIETEX MONOFILAMENT POLYESTER MESH
K090858 · FTL
Sofradim Production
General & Plastic Surgery · 37d
Cleared May 06, 2009
LIGAFIX INTERFACE SCREW
K090994 · HWC
Science For Biomaterials
Orthopedic · 29d
Cleared May 06, 2009
VONFLEX PUTTY
K091267 · ELW
Vericom Co., Ltd.
Dental · 6d
Cleared May 05, 2009
GBS PNA FISH
K082612 · OAH
Advandx, Inc.
Microbiology · 238d
Cleared May 05, 2009
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES,...
K083291 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 179d