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
52777–52800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2009
OPTIMA MR450W
K091536 · LNH
Ge Medical Systems, LLC
Radiology · 52d
Cleared Jul 17, 2009
BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM
K091558 · MWP
Bioptics, Inc.
Radiology · 50d
Cleared Jul 17, 2009
QMS LIDOCAINE CALIBRATORS, MODEL 0374678
K091617 · DLJ
Thermo Fisher Scientific
Toxicology · 44d
Cleared Jul 17, 2009
CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
K091804 · ITX
Philips Ultrasound, Inc.
Radiology · 29d
Cleared Jul 17, 2009
SYNGO VOLUME PERFUSION-CT BODY
K092013 · JAK
Siemens AG Medical Solutions
Radiology · 11d
Cleared Jul 16, 2009
SILENT SLEEP
K082849 · LRK
Craniofacial Pain Center of Idaho
Dental · 290d
Cleared Jul 16, 2009
AKLARUS PHOTOTHERAPY SYSTEM
K083183 · ILY
Hill Laboratories Co.
Physical Medicine · 261d
Cleared Jul 16, 2009
ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010,...
K083419 · FLL
Actherm, Inc.
General Hospital · 239d
Cleared Jul 16, 2009
SQ IS SYSTEM
K090825 · DZE
Neobiotech Co., Ltd.
Dental · 112d
Cleared Jul 16, 2009
AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
K090914 · JAD
Xoft, Inc.
Radiology · 106d
Cleared Jul 16, 2009
SMITH & NEPHEW RF CANNULATE
K090955 · GXI
Smith & Nephew, Inc.
Neurology · 101d
Cleared Jul 16, 2009
MONACO RTP SYSTEM, VMAT OPTION
K091179 · MUJ
Computerized Medical Systems, Inc.
Radiology · 84d
Cleared Jul 16, 2009
ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
K091900 · GDW
Covidien Lp, Formerly Registered AS...
General & Plastic Surgery · 21d
Cleared Jul 16, 2009
VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713
K092088 · INI
Pride Mobility Products Corp.
Physical Medicine · 7d
Cleared Jul 15, 2009
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200
K083903 · DQD
3M Company
Cardiovascular · 198d
Cleared Jul 15, 2009
TREU
K083912 · HWC
Treu-Instrumente GmbH
Orthopedic · 197d
Cleared Jul 15, 2009
SONICAID FM820 AND FM830 ENCORE
K090285 · HGM
Huntleigh Healthcare , Ltd.
Obstetrics & Gynecology · 160d
Cleared Jul 15, 2009
TALOS INTERVERTEBRAL BODY FUSION DEVICE
K090707 · MAX
Meditech Advisors, LLC
Orthopedic · 120d
Cleared Jul 15, 2009
TIGRT TPS
K090893 · MUJ
Linatech, LLC
Radiology · 106d
Cleared Jul 15, 2009
STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
K091008 · DWA
Sorin Group Deutschland GmbH
Cardiovascular · 97d
Cleared Jul 15, 2009
MODIFICATION TO MEDICOMPASS CONNECT
K091021 · DRG
Imetrikus, Inc.
Cardiovascular · 97d
Cleared Jul 15, 2009
TRIMED STERILE PRODUCT
K091156 · HRS
TriMed, Inc.
Orthopedic · 85d
Cleared Jul 15, 2009
CD HORIZON SPINAL SYSTEM
K091442 · NKB
Medtronic Sofamor Danek
Orthopedic · 61d
Cleared Jul 15, 2009
PASCAL PHOTOCOAGULATOR, PASCAL-US
K091666 · GEX
Optimedica Corporation
General & Plastic Surgery · 36d