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
44857–44880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2012
SPACELABS ARKON ANESTHESIA WORKSTATION
K113051 · CBK
Spacelabs Healthcare
Anesthesiology · 161d
Cleared Mar 22, 2012
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
K113117 · GWQ
Nihon Kohden America, Inc.
Neurology · 153d
Cleared Mar 22, 2012
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER...
K113220 · LOX
Boston Scientific Corporation
Cardiovascular · 142d
Cleared Mar 22, 2012
GENII GI 4000 ELECTROSUGICAL GENERATOR
K113265 · GEI
Genii, Inc.
General & Plastic Surgery · 139d
Cleared Mar 22, 2012
PHYSIOLOGICAL MONITOR, PATIENT MONITOR
K113441 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 122d
Cleared Mar 22, 2012
INTELLIVUE PATIENT MONITOR
K113657 · MHX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 101d
Cleared Mar 22, 2012
INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET
K113798 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 90d
Cleared Mar 21, 2012
HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM
K102900 · LGZ
Hei, Inc.
General Hospital · 538d
Cleared Mar 21, 2012
NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K112005 · LYY
Ug Healthcare (Usa), Inc.
General Hospital · 252d
Cleared Mar 21, 2012
NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES
K112012 · LZA
Ug Healthcare (Usa), Inc.
General Hospital · 252d
Cleared Mar 21, 2012
ZOLL X SERIES
K112432 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 211d
Cleared Mar 21, 2012
UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR
K112887 · DYB
Upstream Peripheral Technologies
Cardiovascular · 173d
Cleared Mar 21, 2012
POSEY BED
K113357 · OYS
J. T. Posey Co.
General Hospital · 128d
Cleared Mar 21, 2012
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL
K113818 · EBC
Pulpdent Corporation
Dental · 85d
Cleared Mar 21, 2012
PULTOL
K113865 · DQA
Sharp Corporation
Anesthesiology · 82d
Cleared Mar 21, 2012
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
K120070 · HRS
Synthes (Usa)
Orthopedic · 72d
Cleared Mar 21, 2012
INTRAUTERINE INSEMINATION (IUI) CATHETER
K120154 · MQF
Catheter Research, Inc.
Obstetrics & Gynecology · 63d
Cleared Mar 20, 2012
NEWDEAL INTERPHALANGEAL IMPLANT
K103623 · HTY
Newdeal Sas
Orthopedic · 466d
Cleared Mar 20, 2012
V1 SYSTEM
K111756 · FDF
Olympus Medical Systems Corp.
Gastroenterology & Urology · 272d
Cleared Mar 20, 2012
M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER
K112100 · DQY
Vascular Solutions, Inc.
Cardiovascular · 242d
Cleared Mar 20, 2012
MAMMOTOME ELITE BIOPSY SYSTEM
K112411 · KNW
Devicor Medical Products, Inc.
Gastroenterology & Urology · 211d
Cleared Mar 20, 2012
PIPELINE CR PRIMARY KNEE SYSTEM
K113122 · JWH
Pipeline Orthopedics
Orthopedic · 151d
Cleared Mar 20, 2012
ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM
K113475 · OCL
Endoscopic Technologies, Inc. D/B/A...
Cardiovascular · 119d
Cleared Mar 20, 2012
SYNGO RT INTERFACE
K120363 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 43d