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
43633–43656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 2012
POWER-FREE NITRILE PATIENT EXAMINATION GLOVES
K121526 · LZA
Shandong Junchi Medical Products Co.,...
General Hospital · 72d
Cleared Aug 03, 2012
SHANGRING
K121789 · HFX
Wuhu Snna Medical Treatment Appliance...
Obstetrics & Gynecology · 45d
Cleared Aug 03, 2012
PICC CONVENIENCE KIT
K121990 · LJS
Navilyst Medical, Inc.
General Hospital · 28d
Cleared Aug 03, 2012
BE PLUS LTM AMPLIFIER GWI AMPLIFIER
K121996 · GWL
Eb Neuro S.P.A.
Neurology · 25d
Cleared Aug 03, 2012
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
K122118 · JXG
Codman & Shurtleff, Inc.
Neurology · 17d
Cleared Aug 02, 2012
ABACUS 3CP
K111534 · GKZ
Diatron U.S., Inc.
Hematology · 427d
Cleared Aug 02, 2012
DISITAL BLOOD PRESSURE MONITOR
K112620 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 329d
Cleared Aug 02, 2012
SOFTSEAL-C
K112864 · QSY
Chitogen, Inc.
General & Plastic Surgery · 307d
Cleared Aug 02, 2012
MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P
K120430 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 171d
Cleared Aug 02, 2012
MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE
K120734 · LLZ
Microsoft Corp.
Radiology · 146d
Cleared Aug 02, 2012
HEADWAY DUO MICROCATHETER
K120917 · DQO
MicroVention, Inc.
Cardiovascular · 128d
Cleared Aug 02, 2012
POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K121157 · LYZ
Shijazhuang Jiuyuan Plastic Co., Ltd.
General Hospital · 108d
Cleared Aug 02, 2012
SENSUS
K121184 · GZJ
Neurometrix, Inc.
Neurology · 106d
Cleared Aug 02, 2012
BT-200V VASCULAR DOPPLER
K121267 · HGM
Bistos Co., Ltd.
Radiology · 98d
Cleared Aug 02, 2012
DRAGON LW
K121410 · IZL
Sedecal., Sa.
Radiology · 83d
Cleared Aug 02, 2012
PERIFUSE CATHETER
K121525 · CAZ
Smiths Medical Asd, Inc.
Anesthesiology · 71d
Cleared Aug 02, 2012
SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS
K121867 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 37d
Cleared Aug 02, 2012
LANX SPINAL FIXATION SYSTEM
K121940 · NKB
Lanx, Inc.
Orthopedic · 31d
Cleared Aug 02, 2012
ELI 280 ELECTROCARDIOGRAPH
K122073 · DPS
Mortara Instrument, Inc.
Cardiovascular · 17d
Cleared Aug 02, 2012
PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
K122121 · DXG
Pulsion Medical Systems SE
Cardiovascular · 16d
Cleared Aug 01, 2012
ORION MICRO CATHETER
K113289 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 268d
Cleared Aug 01, 2012
CELOX GAUZE PRO
K113560 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 244d
Cleared Aug 01, 2012
SOLAR GI
K121014 · FFX
Medical Measurement Systems B.V.
Gastroenterology & Urology · 120d
Cleared Aug 01, 2012
MEDILAS H RFID LASER FIBER
K121938 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 30d