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
45121–45144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 2012
WAGNER CONE PROSTHESIS SYSTEM
K113556 · LZO
Zimmer GmbH
Orthopedic · 78d
Cleared Feb 17, 2012
HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY
K113627 · MTJ
Orthocon
General & Plastic Surgery · 71d
Cleared Feb 17, 2012
CLOSER TO NATURE ELECTRIC BREAST PUMP
K113664 · HGX
Mayborn Group Limited
Obstetrics & Gynecology · 66d
Cleared Feb 17, 2012
NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
K120081 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 37d
Cleared Feb 17, 2012
ACE STAPLER AND CARTRIDGE
K120147 · OCW
Barosense, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 17, 2012
ARTHREX KNOTLESS SUTURETAK ANCHOR
K120155 · MBI
Arthrex, Inc.
Orthopedic · 30d
Cleared Feb 17, 2012
ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM
K120163 · HRS
Acute Innovations, LLC
Orthopedic · 29d
Cleared Feb 17, 2012
AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET
K120272 · KNT
Kentec Medical, Inc.
Gastroenterology & Urology · 18d
Cleared Feb 17, 2012
CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM
K120321 · IYN
Philips Health Care
Radiology · 15d
Cleared Feb 16, 2012
EAUM TOTAL KNEE SYSTEM
K110404 · JWH
Corentec Co., Ltd.
Orthopedic · 367d
Cleared Feb 16, 2012
PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS...
K110825 · MKJ
Philips Medical Systems
Cardiovascular · 330d
Cleared Feb 16, 2012
ICON (TM) MODULAR PEDICLE SCREW SYSTEM
K111448 · NKB
Orthofix, Inc.
Orthopedic · 268d
Cleared Feb 16, 2012
UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
K111473 · CBK
Impact Instrumentation, Inc.
Anesthesiology · 265d
Cleared Feb 16, 2012
WAVES
K111521 · KDN
Waters Medical Systems, LLC
Gastroenterology & Urology · 260d
Cleared Feb 16, 2012
STLASE
K111689 · GEX
Dental Photonics, Inc.
General & Plastic Surgery · 245d
Cleared Feb 16, 2012
BD MAX GBS ASSAY, BD MAX INSTRUMENT
K111860 · NJR
Becton, Dickinson & CO
Microbiology · 231d
Cleared Feb 16, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
K111874 · LFR
Abbott Laboratories
Chemistry · 230d
Cleared Feb 16, 2012
3B WILLOW
K112271 · BZD
3B Products, LLC
Anesthesiology · 192d
Cleared Feb 16, 2012
KOWA VX-20
K112330 · HKI
Kowa Co. , Ltd.
Ophthalmic · 188d
Cleared Feb 16, 2012
EVIS EXERA III VIDEO SYSTEM
K112680 · FDF
Olympus Medical Systems Corporation
Gastroenterology & Urology · 155d
Cleared Feb 16, 2012
PLEURX PLEURAL CATHETER SYSTEMS
K112831 · DWM
Care Fusion
Anesthesiology · 141d
Cleared Feb 16, 2012
SURFACE BEACON TRANSPONDERS
K112841 · IYE
Calypso Medical Technologies, Inc.
Radiology · 140d
Cleared Feb 16, 2012
CS IMAGING
K113419 · LLZ
Trophy
Radiology · 90d
Cleared Feb 16, 2012
3DI
K113442 · LLZ
Shina Systems , Ltd.
Radiology · 87d