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
37609–37632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 2014
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K141678 · NTE
Abbott Vascular
Cardiovascular · 29d
Cleared Jul 21, 2014
BABYMEG BIOMAGNETOMETER SYSTEM
K133419 · OLY
Tristan Technologies, Inc.
Neurology · 256d
Cleared Jul 21, 2014
THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE...
K134031 · LOX
Boston Scientific Corporation
Cardiovascular · 202d
Cleared Jul 21, 2014
CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR...
K140726 · FDI
Boston Scientific Corp
Gastroenterology & Urology · 119d
Cleared Jul 21, 2014
BIOSURE HEALICOIL PK INTERFERENCE SCREW
K140879 · MBI
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Jul 21, 2014
EXCIA TOTAL HIP SYSTEM
K140915 · LZO
Aesculap Implant Systems, LLC
Orthopedic · 102d
Cleared Jul 21, 2014
AZUL PERSONAL LUBRICANT
K141034 · NUC
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 90d
Cleared Jul 18, 2014
MEDYSSEY ANTERIOR CERVICAL FUSION CAGE
K132732 · ODP
Medyssey USA, Inc.
Orthopedic · 318d
Cleared Jul 18, 2014
PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE
K133233 · NUC
Pjur Group Luxembourg S.A.
Obstetrics & Gynecology · 270d
Cleared Jul 18, 2014
ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM
K133551 · NHA
Zimmer Dental, Inc.
Dental · 241d
Cleared Jul 18, 2014
POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES
K133699 · LZA
Pt. Smartglove Indonesia
General Hospital · 227d
Cleared Jul 18, 2014
ALMA DIODE TABLETOP LASER
K140005 · GEX
Alma Lasers , Ltd.
General & Plastic Surgery · 197d
Cleared Jul 18, 2014
AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
K140082 · PHX
Tornier S.A.S.
Orthopedic · 186d
Cleared Jul 18, 2014
E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES
K140200 · GXZ
Neuroinvent, Inc.
Neurology · 172d
Cleared Jul 18, 2014
GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER
K140518 · NPL
Geistlich Pharma AG
Dental · 140d
Cleared Jul 18, 2014
LEVO TINNITUS MASKING SOFTWARE DEVICE
K140845 · KLW
Otoharmonics Corp
Ear, Nose, Throat · 107d
Cleared Jul 18, 2014
SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL
K140897 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 102d
Cleared Jul 18, 2014
OPTILITE C1 INACTIVATOR KIT
K141100 · DBA
The Binding Site Group , Ltd.
Immunology · 80d
Cleared Jul 18, 2014
NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
K141118 · LIT
Ev3, Inc.
Cardiovascular · 79d
Cleared Jul 18, 2014
JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND...
K141219 · HTN
Biomet Manufacturing Corp
Orthopedic · 67d
Cleared Jul 18, 2014
ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
K141265 · JHW
Elitechgroup
Chemistry · 64d
Cleared Jul 18, 2014
ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS
K141280 · LPL
Seinoh Optical Co. , Ltd.
Ophthalmic · 63d
Cleared Jul 18, 2014
VARIAX DISTAL RADIUS PLATING SYSTEM
K141430 · HRS
Stryker Leibinger GmbH & Co KG
Orthopedic · 49d
Cleared Jul 18, 2014
ARTHREX PIP DART
K141577 · HTY
Arthrex, Inc.
Orthopedic · 35d