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
41497–41520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 2013
PERSONAL HEALTH CENTER (PHC)
K122076 · DXN
Adflow Health Networks, Inc.
Cardiovascular · 273d
Cleared Apr 15, 2013
HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
K122304 · DBA
The Binding Site Group , Ltd.
Immunology · 257d
Cleared Apr 15, 2013
YOULASER CO2 LASER
K123573 · GEX
Quanta System Spa
General & Plastic Surgery · 146d
Cleared Apr 15, 2013
OPTICROSS 40 MHZ CORONARY IMAGING CATHETER
K123621 · OBJ
Boston Scientific Corp
Cardiovascular · 143d
Cleared Apr 15, 2013
VIVASIGHT-DL SYSTEM
K123853 · CBI
Etview , Ltd.
Anesthesiology · 122d
Cleared Apr 15, 2013
Z CARTRIDGE IOL DELIVERY SYSTEM
K123888 · MSS
Aaren Scientific, Inc.
Ophthalmic · 118d
Cleared Apr 15, 2013
AESCULAP CESPACE XP
K123909 · ODP
Aesculap Implant System, Inc.
Orthopedic · 117d
Cleared Apr 15, 2013
LOSPA TOTAL KNEE REPLACEMENT SYSTEM
K130673 · JWH
Corentec Co., Ltd.
Orthopedic · 34d
Cleared Apr 12, 2013
EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)
K113439 · NIY
Euroimmun US
Immunology · 508d
Cleared Apr 12, 2013
NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP...
K122223 · BZQ
Philips Medizin Systeme Boeblingen GmbH
Anesthesiology · 261d
Cleared Apr 12, 2013
IOLMASTER 500
K122418 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 247d
Cleared Apr 12, 2013
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE
K122464 · LZA
Industrial Clothings, Ltd.
General Hospital · 242d
Cleared Apr 12, 2013
PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA...
K122537 · IYN
Hitachi Aloka Medical,Ltd. (Hitachi...
Radiology · 235d
Cleared Apr 12, 2013
INTRAMEDULLARY NAIL SYSTEM
K122994 · MNH
Weigao Orthopaedic Device Co., Ltd.
Orthopedic · 197d
Cleared Apr 12, 2013
QUIKCLOT HEMOSTATIC DRESSING
K123387 · QSY
Z-Medica, LLC
General & Plastic Surgery · 161d
Cleared Apr 12, 2013
MICROSLIDER TEARAWAY INTRODUCER SET
K123430 · DYB
Galt Medical Corp.
Cardiovascular · 156d
Cleared Apr 12, 2013
IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
K123935 · NBW
Andon Medical Co., Ltd.
Chemistry · 113d
Cleared Apr 12, 2013
PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K130119 · IYN
Sonoscape Company Limited
Radiology · 86d
Cleared Apr 12, 2013
APTUS HELI-FX AORTIC SECUREMENT SYSTEM
K130677 · OTD
Aptus Endosystems, Inc.
Cardiovascular · 30d
Cleared Apr 12, 2013
BIOMARC GOLD FIDUCIAL MARKER
K130678 · IYE
Carbon Medical Technologies, Inc.
Radiology · 30d
Cleared Apr 12, 2013
LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK
K130761 · JJY
Bio-Rad Laboratories
Immunology · 23d
Cleared Apr 12, 2013
UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM
K130803 · IYN
Samsung Medison Co., Ltd.
Radiology · 21d
Cleared Apr 12, 2013
XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION
K130884 · LLZ
Ge Medical Systems F.I. Haifa
Radiology · 14d
Cleared Apr 12, 2013
ZMED VP4000
K130929 · LLZ
Zmed, Inc.
Radiology · 9d