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
33241–33264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 2015
SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT
K152782 · MQL
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 87d
Cleared Dec 21, 2015
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL...
K152875 · MSV
Inova Diagnostics, Inc.
Immunology · 82d
Cleared Dec 21, 2015
Q Series Diagnostic Ultrasound System
K153085 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 56d
Cleared Dec 21, 2015
Ally Uterine Positioning System
K153092 · LKF
CooperSurgical, Inc.
Obstetrics & Gynecology · 56d
Cleared Dec 21, 2015
Defibrillator Analyzer Variable Load
K153210 · DRL
Bc Group International, Inc.
Cardiovascular · 46d
Cleared Dec 21, 2015
Monster BITE Screw System
K153378 · HWC
Paragon 28
Orthopedic · 28d
Cleared Dec 21, 2015
GR40CW
K153401 · MQB
Samsung Electronics Co., Ltd.
Radiology · 27d
Cleared Dec 21, 2015
HM70A Diagnostic Ultrasound System
K153408 · IYN
Samsung Medison Co., Ltd.
Radiology · 26d
Cleared Dec 21, 2015
Apex Revision Knee System
K153437 · JWH
Omnilife Science
Orthopedic · 24d
Cleared Dec 18, 2015
CUSA Excel+
K150682 · LFL
Integra Lifesciences Corp.
General & Plastic Surgery · 276d
Cleared Dec 18, 2015
Flexipet Denuding Pipette, Flexipet Manipulation Pipette
K150748 · MQH
Cook Incorporated
Obstetrics & Gynecology · 270d
Cleared Dec 18, 2015
O-RING Condom
K150828 · HIS
O-Ring Products, LLC
Obstetrics & Gynecology · 263d
Cleared Dec 18, 2015
LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
K150898 · JXG
Moller Medical GmbH
Neurology · 260d
Cleared Dec 18, 2015
Deployable Oxygen Generation System-Smaill (DOGS-S)
K150930 · CAW
Airsep Corporation
Anesthesiology · 256d
Cleared Dec 18, 2015
MReye Embolization Coils
K150931 · KRD
Cook Incorporated
Cardiovascular · 256d
Cleared Dec 18, 2015
MReye Flipper Detachable Embolization Coil and Delivery System
K150964 · KRD
Cook Incorporated
Cardiovascular · 252d
Cleared Dec 18, 2015
Foresight Intracardiac Echocardiography (ICE) System
K151126 · DQO
Colibri Technologies, Inc.
Cardiovascular · 234d
Cleared Dec 18, 2015
ROSA Brain
K151359 · HAW
Medtech S.A
Neurology · 212d
Cleared CT Dec 18, 2015
Always/Tampax bladder supports
K151413 · HHW
Procter & Gamble
Obstetrics & Gynecology · 205d
Cleared Dec 18, 2015
Breathing circuit bacterial/viral filter
K151498 · CAH
Zhejiang Haisheng Medical Device Co.,...
General Hospital · 197d
Cleared Dec 18, 2015
TRI Dental Implant System
K151916 · DZE
Tri Dental Implants Int. AG
Dental · 158d
Cleared Dec 18, 2015
V8 Balloon Aortic Valvuloplasty Catheter
K152150 · OZT
Intervalve, Inc.
Cardiovascular · 137d
Cleared Dec 18, 2015
Digital Electrocardiograph
K152384 · DPS
Shenzhen Biocare Bio-Medical...
Cardiovascular · 116d
Cleared Dec 18, 2015
Fluent Inflation Device
K152387 · MAV
Vascular Solutions, Inc.
Cardiovascular · 116d