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
41137–41160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 2013
GLUCOSE METER-CHECK SOLUTION FOR TAIDOC
K131136 · JJX
Bionostics, Inc.
Chemistry · 39d
Cleared May 31, 2013
WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
K131232 · DJR
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 30d
Cleared May 31, 2013
MAXTORQUE SCREW SYSTEM
K131324 · HWC
Orthohelix Surgical Designs, Inc.
Orthopedic · 23d
Cleared May 30, 2013
HUMAN IGA CSF KIT FOR USE ON SPAPLUS
K120901 · CFN
The Binding Site Group , Ltd.
Immunology · 430d
Cleared May 30, 2013
ORAMOIST
K122663 · LFD
Quantum, Inc.
Dental · 272d
Cleared May 30, 2013
PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
K123202 · LPL
CooperVision, Inc.
Ophthalmic · 230d
Cleared May 30, 2013
BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT
K123491 · NHA
Biodenta Swiss AG
Dental · 198d
Cleared May 30, 2013
CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST,...
K123844 · JHI
Chemtron Biotech, Inc.
Chemistry · 168d
Cleared May 30, 2013
MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE
K130287 · GXY
Rhythmlink International, LLC
Neurology · 114d
Cleared May 30, 2013
TRANSTEK BODY FAT ANALYZER
K130311 · MNW
Guangdong Transtek Medical...
Gastroenterology & Urology · 111d
Cleared May 30, 2013
IDRIVE ULTRA STERILIZATION TRAY
K130532 · KCT
Covidien, Formerly US Surgical A...
General Hospital · 90d
Cleared May 30, 2013
ALEUTIAN SPINAL SYSTEM
K130699 · MAX
K2m, Inc.
Orthopedic · 77d
Cleared May 30, 2013
TAKE 1 ADVANCE
K130869 · ELW
Sybron Dental Specialties
Dental · 62d
Cleared May 30, 2013
MEMORY PUMP MODEL Y4947
K131027 · HGX
Tomy International
Obstetrics & Gynecology · 48d
Cleared May 30, 2013
ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
K131199 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 34d
Cleared May 30, 2013
RAMPART O
K131216 · MAX
Spineology, Inc.
Orthopedic · 30d
Cleared May 30, 2013
FLASH AR PENTA / FLASH AR PENTA QUICK
K131404 · ELW
3M Deutschland GmbH
Dental · 15d
Cleared May 29, 2013
VASOSTAT HEMOSTASIS DEVICE
K123041 · DXC
Forge Medical, Inc.
Cardiovascular · 243d
Cleared May 29, 2013
FREND PSA PLUS (REAGENT CARTRIDGE)
K124056 · LTJ
Nanoentek, Inc.
Immunology · 149d
Cleared May 29, 2013
EXSPIRON 1XI
K130170 · BZK
Respiratory Motion, Inc.
Anesthesiology · 125d
Cleared May 29, 2013
MR PERMEABILITY
K130278 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 113d
Cleared May 29, 2013
STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE
K130288 · DSH
Cardiac Insight, Inc.
Cardiovascular · 113d
Cleared May 29, 2013
SCANORA 3DX
K130297 · OAS
Palodex Group OY
Radiology · 112d
Cleared CT May 29, 2013
MEDIENT MIDDLE TURBINATE IMPLANT
K130354 · LYA
Entrigue Surgical, Inc.
Ear, Nose, Throat · 106d