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
44569–44592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 2012
PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
K120664 · JGY
Abaxis, Inc.
Chemistry · 50d
Cleared Apr 24, 2012
SLEEPWEAVER ELAN NASAL CPAP MASK
K120757 · BZD
Circadiance, LLC
Anesthesiology · 42d
Cleared Apr 24, 2012
APEX KIRSCHNER WIRES AND STEINMANN PINS
K121004 · HTY
Apex Tools & Orthopedics Co.
Orthopedic · 21d
Cleared Apr 23, 2012
FLAT PANEL DETECTOR
K111824 · MQB
Canon Inc. -Medical Equipment Group
Radiology · 300d
Cleared Apr 23, 2012
HOME PREGNANCY TEST
K112315 · JHI
Newscen Coast Bio-Pharmaceutical Co.,...
Chemistry · 256d
Cleared Apr 23, 2012
SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
K113857 · HQB
Synergetics, Inc.
Ophthalmic · 115d
Cleared Apr 23, 2012
VISIA
K120207 · LLZ
Mevis Medical Solutions AG
Radiology · 90d
Cleared Apr 20, 2012
OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190
K111425 · HET
Olympus Medical Systems Corp.
Obstetrics & Gynecology · 333d
Cleared Apr 20, 2012
SALINE WOUND WASH
K112666 · FRO
Nanoplas, Inc.
General & Plastic Surgery · 220d
Cleared Apr 20, 2012
PALTOP DENTAL IMPLANT SYSTEM
K112795 · DZE
Paltop Advanced Dental Solutions, Ltd.
Dental · 207d
Cleared Apr 20, 2012
EARLOGIC OAE TESTER
K112992 · EWO
Earlogic Corporation
Ear, Nose, Throat · 197d
Cleared Apr 20, 2012
3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W
K113240 · LLZ
Eizo Nanao Corporation
Radiology · 170d
Cleared Apr 20, 2012
RAPID PROGRAMMER
K113611 · GZB
St Jude Medical
Neurology · 136d
Cleared Apr 20, 2012
MCKESSON ANESTHESIA CARE
K113633 · BSZ
Mckesson Technologies, Inc.
Anesthesiology · 134d
Cleared Apr 20, 2012
FENESTRATED NERVE BLOCK NEEDLE
K113662 · CAZ
Imd, Inc.
Anesthesiology · 135d
Cleared Apr 20, 2012
SAFETY SCREW CONNECTOR
K113719 · KNT
Abbott Laboratories
Gastroenterology & Urology · 123d
Cleared Apr 20, 2012
EXCELSIOR XT-27 MICROCATHETER
K113778 · DQY
Stryker Neurovascular
Cardiovascular · 120d
Cleared Apr 20, 2012
EASYCARE TX SYSTEM (CONNEXUNS)
K113780 · BZD
Resmed, Ltd.
Anesthesiology · 120d
Cleared Apr 20, 2012
BLUWHITE DIAMOND DENTAL BURS MODIFIED
K120037 · DZP
Beavers Dental, Div. Sybron Canada, Ltd.
Dental · 106d
Cleared Apr 20, 2012
SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML
K120051 · CAF
Nephron Pharmaceuticals Corp.
Anesthesiology · 105d
Cleared Apr 20, 2012
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES
K120208 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 87d
Cleared Apr 20, 2012
NEO CR KNEE SYSTEM
K120313 · JWH
Pipeline Orthopedics
Orthopedic · 79d
Cleared Apr 20, 2012
GORE DRYSEAL SHEATH
K120428 · DYB
W.L. Gore & Associates, Inc.
Cardiovascular · 67d
Cleared Apr 20, 2012
NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300...
K120853 · GZI
Bioness, Inc.
Neurology · 30d