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

Filters: Cleared only ×
175,820 results
33577–33600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 2015
Turbo-Power Laser Atherectomy Catheter
K152181 · MCW
Spectranetics, Inc.
Cardiovascular · 100d
Cleared Nov 12, 2015
Arthrex iBalance TKA System
K152382 · JWH
Arthrex, Inc.
Orthopedic · 80d
Cleared Nov 12, 2015
PANTHER Cutter Stapler
K152618 · GDW
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT...
General & Plastic Surgery · 59d
Cleared Nov 12, 2015
ATLANTIS Anterior Cervical Plate System
K152623 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 59d
Cleared Nov 12, 2015
VLP Mini-Mod Talus Plates
K152976 · HRS
Smith & Nephew, Inc.
Orthopedic · 35d
Cleared Nov 12, 2015
FUJIFILM SonoSite iViz Ultrasound System
K152983 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 34d
Cleared Nov 10, 2015
EzFuze Implant System
K150211 · HWC
Vilex IN Tennessee, Inc.
Orthopedic · 284d
Cleared CT Nov 10, 2015
HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First...
K150916 · QSY
Hem Con Medical Technologies, Inc.
General & Plastic Surgery · 218d
Cleared Nov 10, 2015
FIBERGRAFT BG Morsels
K151154 · MQV
Prosidyan, Inc.
Orthopedic · 194d
Cleared Nov 10, 2015
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K151315 · EOQ
Boston Scientific Corporation
Ear, Nose, Throat · 176d
Cleared Nov 10, 2015
Integrity Spine Lumbar Interbody Fusion System
K151819 · MAX
Integrity Spine Lumbar Interbody...
Orthopedic · 127d
Cleared Nov 10, 2015
PacEndo Sodium Hyprochlorite
K151852 · KJJ
Pac-Dent International, Inc.
Dental · 126d
Cleared Nov 10, 2015
ATAL 9
K152151 · MQB
Atlaim Corporation
Radiology · 99d
Cleared Nov 10, 2015
illumigene Pertussis DNA Amplification Assay
K152285 · OZZ
Meridian Bioscience, Inc.
Microbiology · 90d
Cleared Nov 10, 2015
TR BAND Radial Compression Device
K152525 · DXC
Terumo Medical Corporation
Cardiovascular · 68d
Cleared Nov 10, 2015
CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors
K153058 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 20d
Cleared Nov 10, 2015
Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S
K153060 · MUH
Rayence Co., Ltd.
Radiology · 20d
Cleared Nov 09, 2015
Divine 9
K150397 · NUC
Carrashield Labs, Inc.
Obstetrics & Gynecology · 264d
Cleared Nov 09, 2015
Patient Contoured Implant-PEEK (PCI-PEEK)
K151382 · GXN
KLS-Martin L.P.
Neurology · 171d
Cleared Nov 09, 2015
Thermofit
K151946 · IYE
Orfit Industries
Radiology · 118d
Cleared Nov 09, 2015
Wrist - Type Fully Automatic Digital Blood Pressure Monitor
K152426 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 75d
Cleared Nov 09, 2015
First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse...
K152551 · DJG
W.H.P.M., Inc.
Toxicology · 62d
Cleared Nov 06, 2015
JDENTALCARE Implant System
K143142 · DZE
Jdentalcare Srl
Dental · 368d
Cleared Nov 06, 2015
MEDLINE SHARPS CONTAINERS
K143693 · MMK
Medline Industries, Inc.
General Hospital · 317d