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
39985–40008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2013
BIOROOT RCS
K130601 · KIF
Novocol, Inc.
Dental · 224d
Cleared Oct 17, 2013
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
K130719 · OGZ
Infraredx, Inc.
Cardiovascular · 213d
Cleared Oct 17, 2013
LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF
K130942 · DXQ
Legacy Medical, Inc.
Cardiovascular · 196d
Cleared Oct 17, 2013
TRUE SPINAL FIXATION SYSTEM
K130958 · MNI
Innovative Surgical Designs
Orthopedic · 195d
Cleared Oct 17, 2013
FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
K131013 · NBW
Nova Biomedical Corporation
Chemistry · 189d
Cleared Oct 17, 2013
UNIVATION
K131167 · HRY
Aesculap Implant Systems, LLC
Orthopedic · 176d
Cleared Oct 17, 2013
AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE
K131459 · JDW
Aap Implantate AG
Orthopedic · 150d
Cleared Oct 17, 2013
UNIVERSAL NEURO 3 SYSTEM
K131775 · GWO
Stryker
Neurology · 122d
Cleared Oct 17, 2013
INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
K131872 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 115d
Cleared Oct 17, 2013
SOMNOLYZER 24X7
K131994 · MNR
Respironics, Inc.
Anesthesiology · 111d
Cleared Oct 17, 2013
TRANSCEND AUTO
K132127 · BZD
Somnetics International, Inc.
Anesthesiology · 99d
Cleared CT Oct 17, 2013
APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)
K132251 · LSL
Hologic / Gen-Probe Incorporated
Microbiology · 90d
Cleared Oct 17, 2013
GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
K132272 · NBW
Glooko, Inc.
Chemistry · 87d
Cleared Oct 17, 2013
STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER
K132430 · LIT
Boston Scientific Corp
Cardiovascular · 73d
Cleared Oct 17, 2013
IMAGENET 5 PC SOFTWARE SYSTEM
K132438 · NFJ
Topcon Medical Systems, Inc.
Ophthalmic · 73d
Cleared Oct 17, 2013
MRSA/SA ELITE MGB, ELITE MGB SOFTWARE
K132468 · NQX
Elitechgroup Epoch Biosciences
Microbiology · 71d
Cleared Oct 17, 2013
HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE +...
K132612 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 57d
Cleared Oct 17, 2013
DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM
K132636 · LLZ
Smith & Nephew, Inc.
Radiology · 56d
Cleared Oct 17, 2013
SITE-RITE VISION II ULTRASOUND SYSTEM
K132942 · IYN
C.R. Bard, Inc.
Radiology · 28d
Cleared Oct 16, 2013
MEDLINE SUCTION COAGULATOR
K122949 · GEI
Medline Industries, Inc.
General & Plastic Surgery · 387d
Cleared Oct 16, 2013
PROW FUSION
K130254 · MAX
Nlt Spine, Ltd.
Orthopedic · 257d
Cleared Oct 16, 2013
BRAEMAR CARDIOKEY HOLTER RECORDER
K130294 · MWJ
Braemar Manufacturing, LLC
Cardiovascular · 252d
Cleared Oct 16, 2013
PEDIATRIC FOLDING WHEELCHAIR
K130644 · LBE
Columbia Medical Mfg, LLC
Physical Medicine · 219d
Cleared Oct 16, 2013
NASAL COMFORT FREEDOM
K130686 · BZD
Lakeview Sleep Center
Anesthesiology · 217d