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
31321–31344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 2016
Wireless Smart Gluco-Monitoring System
K153278 · NBW
Andon Health Co, Ltd.
Chemistry · 281d
Cleared Aug 19, 2016
iHealth Align Gluco-Monitoring system
K153286 · NBW
Andon Health Co, Ltd.
Chemistry · 281d
Cleared Aug 19, 2016
Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit,...
K153347 · GWM
Codman & Shurtleff, Inc.
Neurology · 273d
Cleared Aug 19, 2016
Kerecis SecureMesh
K153364 · OXE
Kerecis Limited
General & Plastic Surgery · 273d
Cleared Aug 19, 2016
MADgic Laryngo-Tracheal Mucosal Atomization Device
K153470 · CCT
Teleflex Medical
Anesthesiology · 261d
Cleared Aug 19, 2016
InMode System MiniFX Handpiece
K160329 · PBX
Inmode MD , Ltd.
General & Plastic Surgery · 196d
Cleared Aug 19, 2016
Electrosurgical disposable grounding pads
K160366 · ODR
Top-Rank Health Care Co., Ltd.
General & Plastic Surgery · 192d
Cleared Aug 19, 2016
Microcyn Plus Wound Care Solution
K161034 · FRO
Oculus Innovative Sciences
General & Plastic Surgery · 128d
Cleared Aug 19, 2016
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
K161249 · LDF
Medtronic
Cardiovascular · 108d
Cleared Aug 19, 2016
DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA...
K161287 · DQO
Medtronic Vascular
Cardiovascular · 102d
Cleared Aug 19, 2016
Valeo II Interbody Fusion Device System
K161405 · MAX
Amedica Corp.
Orthopedic · 91d
Cleared Aug 19, 2016
0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle
K162030 · MEG
Sol-Millennium Medical, Inc.
General Hospital · 28d
Cleared Aug 18, 2016
Fingertip Pulse Oximeter
K152091 · DQA
Jiangsu Konsung Bio-Medical Science &...
Anesthesiology · 388d
Cleared Aug 18, 2016
Medke Oximetry Finger Sensor
K152390 · DQA
Shenzhen Medke Technology Co., Ltd.
Anesthesiology · 360d
Cleared Aug 18, 2016
S-Wire Guidewire System
K153397 · DQX
Concert Medical, LLC
Cardiovascular · 268d
Cleared Aug 18, 2016
PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
K153440 · FPA
C.R. Bard, Inc.
General Hospital · 265d
Cleared Aug 18, 2016
Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access...
K153651 · JLW
Beckman Coulter, Inc.
Chemistry · 241d
Cleared Aug 18, 2016
Reprocessed Compression Garments
K161105 · JOW
Covidien
Cardiovascular · 121d
Cleared Aug 18, 2016
Vein Clamps, Artery Clamps
K161315 · DXC
Aros Surgical Instruments Corporation
Cardiovascular · 99d
Cleared Aug 18, 2016
Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit
K161375 · OCC
Alere Scarborough, Inc.
Microbiology · 92d
Cleared Aug 18, 2016
Bullfrog Micro-Infusion Device
K161402 · KRA
Mercator Medsystems, Inc.
Cardiovascular · 90d
Cleared Aug 18, 2016
SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System
K162045 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 24d
Cleared Aug 18, 2016
Sentinella 102, Sentinella 102 Horus
K162052 · IYX
General Equipment For Medical Imaging...
Radiology · 24d
Cleared Aug 17, 2016
Wrist Pulse Oximeter
K152089 · DQA
Jiangsu Konsung Bio-Medical Science &...
Anesthesiology · 387d