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
76513–76536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 2002
LYMPHA VISION-EXPERT
K003896 · GXY
Bexley Trading, Inc.
Neurology · 492d
Cleared Apr 24, 2002
DATASCOPE'S 8FR. ALT B IAB
K020257 · DSP
Datascope Corp.
Cardiovascular · 90d
Cleared Apr 24, 2002
MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS
K020289 · LNH
Machnet BV
Radiology · 86d
Cleared Apr 24, 2002
AGC SPEZIALLEGIERUNG
K020347 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 79d
Cleared Apr 24, 2002
JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA
K020515 · DWF
Jostra AG
Cardiovascular · 68d
Cleared Apr 24, 2002
POLYMEDCO HBA1C TEST
K020532 · LCP
Polymedco, Inc.
Hematology · 64d
Cleared Apr 24, 2002
SIMPLICITY
K020570 · KLE
Apex Dental Materials, Inc.
Dental · 62d
Cleared Apr 24, 2002
FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL
K020601 · MOS
Odin Medical Technologies , Ltd.
Radiology · 61d
Cleared Apr 24, 2002
H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE...
K020954 · LKF
Ackrad Laboratories
Obstetrics & Gynecology · 30d
Cleared Apr 24, 2002
MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
K021103 · LKJ
Zeus Scientific, Inc.
Immunology · 19d
Cleared Apr 23, 2002
STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM
K012387 · BZM
Stethographics, Inc.
Anesthesiology · 270d
Cleared Apr 23, 2002
DIASOL-BICARB
K020230 · KPO
Diasol, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 23, 2002
NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)
K020300 · KPS
Syntermed, Inc.
Radiology · 84d
Cleared Apr 23, 2002
INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL,...
K020495 · MOS
Surgi-Vision, Inc.
Radiology · 68d
Cleared Apr 23, 2002
SYNTHES TRANSLATING MAXILLARY DISTRACTOR
K020505 · JEY
Synthes (Usa)
Dental · 67d
Cleared Apr 23, 2002
WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300
K020604 · DWJ
Nellcor Puritan Bennett, Inc.
Cardiovascular · 57d
Cleared Apr 23, 2002
ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM...
K020838 · LYY
Ar Alliance Healthcare Sdn. Bhd.
General Hospital · 40d
Cleared Apr 23, 2002
ANNULOFLO SYSTEM, MITRAL MODEL AR700
K021051 · KRH
Sulzer Carbomedics, Inc.
Cardiovascular · 22d
Cleared Apr 22, 2002
TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
K013865 · CBI
Cook, Inc.
Anesthesiology · 152d
Cleared Apr 22, 2002
MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS
K013905 · MNR
Pro-Tech Services, Inc.
Anesthesiology · 147d
Cleared Apr 22, 2002
HOMMED CENTRAL STATION
K020184 · DXN
Hommed, LLC
Cardiovascular · 94d
Cleared Apr 22, 2002
SNAP EEG MONITOR
K020218 · OLW
Nicolet Biomedical, Inc.
Neurology · 90d
Cleared Apr 22, 2002
SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP)
K020244 · KWQ
Synthes Spine
Orthopedic · 88d
Cleared Apr 22, 2002
MOTION TRACKING
K020294 · IYE
Accuray, Inc.
Radiology · 84d