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
73537–73560 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 2003
DAVOL ARTHROVENT OUTFLOW TUBING
K030307 · HRX
Davol, Inc.
Orthopedic · 15d
Cleared Feb 12, 2003
SLEEPSCREEN/APNOESCREEN CARDIO
K021138 · MNR
Erich Jaeger GmbH
Anesthesiology · 309d
Cleared Feb 12, 2003
FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
K021193 · HDB
Fortune Medical Instrument Corp.
Obstetrics & Gynecology · 303d
Cleared Feb 12, 2003
MINOLTA PULSOX-2
K021469 · DQA
Konica Minolta Sensing, Inc.
Anesthesiology · 281d
Cleared Feb 12, 2003
OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04...
K021580 · LJT
LeMaitre Vascular, Inc.
General Hospital · 274d
Cleared Feb 12, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K021962 · LFL
The Olympus Optical Co.
General & Plastic Surgery · 243d
Cleared Feb 12, 2003
TISSUELINK BIPOLAR FLOATING BALL DEVICE
K022532 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 196d
Cleared Feb 12, 2003
A16 BLOOD FLOW MEASUREMENT SYSTEM
K023707 · JOM
D. E. Hokanson, Inc.
Cardiovascular · 100d
Cleared Feb 12, 2003
FILM PROCESSOR, MODEL LIFE RAY PRO 1000
K023801 · IXW
S.A.I.E.P. S.R.L.
Radiology · 90d
Cleared Feb 12, 2003
FILM PROCESSOR, MODEL LIFE RAY PRO 2500
K023825 · IXW
S.A.I.E.P. S.R.L.
Radiology · 90d
Cleared Feb 12, 2003
WIENER LAB COLINESTERASA AA
K023992 · DIH
Wiener Laboratories Saic
Chemistry · 72d
Cleared Feb 12, 2003
WELCH ALLYN VITAL SIGN MONITOR WITH MP506
K024005 · DXN
Welch Allyn, Inc.
Cardiovascular · 70d
Cleared Feb 12, 2003
HEMOSIL FACTOR VII DEFICIENT PLASMA
K024082 · GJT
Instrumentation Laboratory CO
Hematology · 63d
Cleared Feb 12, 2003
WIENER LAB. BILIRUBINA DIRECT AA
K024116 · CIG
Wiener Laboratories Saic
Chemistry · 61d
Cleared Feb 12, 2003
PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM
K024147 · MQB
Varian Medical Systems, Inc.
Radiology · 58d
Cleared Feb 12, 2003
COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A)...
K024164 · HQD
Metro Optics, Inc.
Ophthalmic · 57d
Cleared Feb 12, 2003
STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE
K030106 · HAW
Medtronic Surgical Navigation...
Neurology · 30d
Cleared Feb 12, 2003
ENHANCE-S PLUS H
K030116 · MQL
Conception Technology, Inc.
Obstetrics & Gynecology · 30d
Cleared Feb 12, 2003
ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002
K030338 · GEX
Curelight, Ltd.
General & Plastic Surgery · 12d
Cleared Feb 11, 2003
MEDSTAR SYSTEM, MODELS 533-300
K020534 · DXH
Cybernet Medical
Cardiovascular · 357d
Cleared Feb 11, 2003
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES
K021852 · GEI
Olympus Optical Co., Ltd.
General & Plastic Surgery · 251d
Cleared Feb 11, 2003
TWLIGHT, MODEL ISP 9600
K022642 · BZD
Invacare Corp.
Anesthesiology · 187d
Cleared Feb 11, 2003
HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM
K022747 · FIP
Hydropure Systems, Inc.
Gastroenterology & Urology · 176d
Cleared Feb 11, 2003
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
K023248 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 134d