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
36505–36528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 2014
G3 Active Plate Large Fragment System
K142938 · HRS
Genesis Fracture Care, Inc.
Orthopedic · 48d
Cleared Nov 26, 2014
WS80A Diagnostic Ultrasound System
K143089 · IYN
Samsung Medison Co., Ltd.
Radiology · 29d
Cleared Nov 26, 2014
Surgisleeve Wound Protector
K143091 · GCJ
Covidien, LLC
General Hospital · 29d
Cleared Nov 25, 2014
AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
K133989 · DXN
Mortara Instrument, Inc.
Cardiovascular · 334d
Cleared Nov 25, 2014
AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY
K140382 · JCT
Merit Medical Systems, Inc.
General & Plastic Surgery · 284d
Cleared Nov 25, 2014
PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
K140535 · HGM
Philips Medizin Systeme Boblingen GmbH
Obstetrics & Gynecology · 266d
Cleared Nov 25, 2014
TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III...
K140768 · DYB
Lepu Medical Technology (Bejing) Co.,...
Cardiovascular · 243d
Cleared Nov 25, 2014
ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY
K141231 · MKJ
Zeller Power Products (Battery Beast,...
Cardiovascular · 196d
Cleared Nov 25, 2014
ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K141333 · ODP
Spinefrontier, Inc.
Orthopedic · 188d
Cleared Nov 25, 2014
ALLY UPS
K141523 · LKF
CooperSurgical, Inc.
Obstetrics & Gynecology · 169d
Cleared Nov 25, 2014
IN:C2 SPINAL FIXATION SYSTME
K141537 · OVE
Spine Smith Holdings, LLC
Orthopedic · 168d
Cleared Nov 25, 2014
GENESIS TOUCH SYSTEM
K141792 · DRG
Honeywell Hommed
Cardiovascular · 146d
Cleared Nov 25, 2014
COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
K141928 · DKB
Roche Diagnostics Operations (Rdo)
Chemistry · 132d
Cleared Nov 25, 2014
TURNPIKE CATHETER
K142065 · DQY
Vascular Solutions, Inc.
Cardiovascular · 118d
Cleared Nov 25, 2014
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL...
K142118 · NHA
Prismatik Dentalcraft, Inc.
Dental · 113d
Cleared Nov 25, 2014
Atricure Cryo Module System
K142203 · GXH
AtriCure, Inc.
Neurology · 106d
Cleared Nov 25, 2014
LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200...
K142270 · LYY
Hartalega Sdb. Bhd.
General Hospital · 102d
Cleared Nov 25, 2014
SNaP Wound Care System
K142272 · OKO
Spiracur, Inc.
General & Plastic Surgery · 102d
Cleared Nov 25, 2014
CoRoent Small Interlock System
K142299 · OVE
Nu Vasive, Incorporated
Orthopedic · 99d
Cleared Nov 25, 2014
Hospira Primary Sets
K142367 · FPA
Hospira, Inc.
General Hospital · 92d
Cleared Nov 25, 2014
Variolink Esthetic
K142389 · EBF
Ivoclar Vivadent, AG
Dental · 90d
Cleared Nov 25, 2014
PREDICATE III GUIDEWIRE
K142393 · DQX
Lake Region Medical
Cardiovascular · 90d
Cleared Nov 25, 2014
Masimo Root Monitoring System and Accesories
K142394 · MWI
Masimo Corporation
Cardiovascular · 90d
Cleared Nov 25, 2014
DR300 HOLTER MONITOR
K142424 · MWJ
North East Monitoring, Inc.
Cardiovascular · 88d