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
57481–57504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 2008
MUSMATE WALKING AID
K073521 · OHI
Musmate, Ltd.
Physical Medicine · 52d
Cleared Feb 04, 2008
ACCIN PEDICLE SCREW SYSTEM
K073531 · MNH
Accelerated Innovation, LLC
Orthopedic · 49d
Cleared Feb 04, 2008
NEUN
K073554 · EBF
Heraeus Kulzer,GmbH
Dental · 48d
Cleared Feb 01, 2008
SPECTRA HAIR REMOVAL LASER
K053527 · GEX
Spectragenics, Inc.
General & Plastic Surgery · 774d
Cleared Feb 01, 2008
DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE
K063350 · BSP
PAJUNK GmbH Medizintechnologie
Anesthesiology · 452d
Cleared Feb 01, 2008
AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC
K070985 · DSB
Osypka Medical, Inc.
Cardiovascular · 301d
Cleared Feb 01, 2008
HRI 6500, 6600 AND 6700 SERIES V2MASKS
K071149 · BZD
Hans Rudolph, Inc.
Anesthesiology · 283d
Cleared Feb 01, 2008
BONALIVE GRANULES
K071199 · MQV
Vivoxid , Ltd.
Orthopedic · 277d
Cleared Feb 01, 2008
NTRAINER SYSTEM
K071866 · HCC
Kcbiomedix, Inc.
Neurology · 210d
Cleared Feb 01, 2008
BS-200 CHEMISTRY ANALYZER, MODE BS-200
K072018 · CFR
Shenzhen Mindray Bio-Medical...
Chemistry · 193d
Cleared Feb 01, 2008
PRISMAFLEX SYSTEM, VERSION 3.20
K072093 · KDI
Gambro
Gastroenterology & Urology · 186d
Cleared Feb 01, 2008
HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE
K072123 · GZJ
Biowave Corporation
Neurology · 183d
Cleared Feb 01, 2008
DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS...
K072270 · NDY
Diazyme Laboratories
Chemistry · 170d
Cleared Feb 01, 2008
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
K072889 · CFN
The Binding Site, Ltd.
Immunology · 114d
Cleared Feb 01, 2008
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
K073200 · DQO
Vascular Solutions, Inc.
Cardiovascular · 80d
Cleared Feb 01, 2008
MSTAR MPD4500
K073457 · LNH
Xinaomdt Technology Co., Ltd.
Radiology · 53d
Cleared Feb 01, 2008
NEOTRACT ANCHOR SYSTEM
K073651 · GAT
Neotract, Inc.
General & Plastic Surgery · 37d
Cleared Feb 01, 2008
SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE
K080106 · DRX
Leonhard Lang GmbH
Cardiovascular · 17d
Cleared Jan 31, 2008
SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER,...
K071646 · FGE
Idev Technologies, Inc.
Gastroenterology & Urology · 227d
Cleared Jan 31, 2008
FILTER CARESTAR 30
K072002 · CAH
Draeger Medical AG & Co. KG
General Hospital · 192d
Cleared Jan 31, 2008
NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX
K072363 · DZE
Biomet 3i, Inc.
Dental · 161d
Cleared Jan 31, 2008
CERVICAL MD, MODEL C10
K072691 · HEX
Sti Medical Systems
Obstetrics & Gynecology · 129d
Cleared Jan 31, 2008
VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER
K072798 · LIT
Abbott Vascular-Vascular Solutions
Cardiovascular · 122d
Cleared Jan 31, 2008
HANDHELD BASE UNIT
K072920 · GJS
Roche Diagnostics Corp.
Hematology · 108d