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
34825–34848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 2015
JUSHA-M23C LCD Monitor
K151238 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 32d
Cleared Jun 11, 2015
Captiva Spine SmartLOX Cervical Plate System
K141332 · KWQ
Captiva Spine
Orthopedic · 386d
Cleared Jun 11, 2015
Personalized Physiology Analytics Engine software
K142512 · PLB
Vgbio, Inc (Dba Physiq)
Cardiovascular · 276d
Cleared Jun 11, 2015
PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
K142577 · GDW
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT...
General & Plastic Surgery · 272d
Cleared Jun 11, 2015
Avenue T TLIF Cage
K142645 · OVD
Ldr Spine USA, Inc.
Orthopedic · 267d
Cleared CT Jun 11, 2015
XP1000 RF
K143559 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 177d
Cleared Jun 11, 2015
DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
K150135 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 141d
Cleared Jun 11, 2015
Synergy Cranial
K150216 · HAW
Medtronic Navigation, Inc.
Neurology · 132d
Cleared Jun 11, 2015
SternSnap Angled Attachment
K150250 · NHA
Sterngold Dental, LLC
Dental · 128d
Cleared Jun 11, 2015
PulmoVia Working Channel
K150280 · EOQ
Sanovas, Inc.
Ear, Nose, Throat · 126d
Cleared Jun 11, 2015
NuVasive CoRoent Small Interbody System
K150362 · ODP
Nu Vasive, Incorporated
Orthopedic · 119d
Cleared Jun 11, 2015
Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.:...
K150373 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 118d
Cleared Jun 11, 2015
EOS PMP, EOS PMP Integrated
K150489 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 106d
Cleared Jun 11, 2015
Tek RMD (Tek Robotic Mobilization Device)
K150548 · IPL
Matia Robotics Mekatroik Sis. Ar-Ge...
Physical Medicine · 100d
Cleared Jun 11, 2015
Pre-Formed Guidewire
K151244 · DQX
Lake Region Medical
Cardiovascular · 31d
Cleared Jun 10, 2015
KM Needles (Acupuncture Needle)
K142920 · MQX
K.M.S., Inc.
General Hospital · 245d
Cleared Jun 10, 2015
Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space...
K143572 · ODP
Osteomed Implantes, Ltda
Orthopedic · 175d
Cleared Jun 10, 2015
GBR System
K143730 · JEY
Jeil Medical Corporation
Dental · 163d
Cleared Jun 10, 2015
LaparoVue
K150569 · GCJ
Buffalo Filter, LLC
General & Plastic Surgery · 96d
Cleared Jun 10, 2015
Affixus Tibial Nailing System
K150867 · HSB
Biomet, Inc.
Orthopedic · 70d
Cleared Jun 10, 2015
2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter
K151253 · PNO
Boston Scientific Limited
Cardiovascular · 29d
Cleared Jun 10, 2015
ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy...
K151260 · MCW
Cardiovascular System, Inc.
Cardiovascular · 29d
Cleared Jun 10, 2015
BD Veritor (TM) System for the Rapid Detection of Flu A+B
K151291 · PSZ
Becton, Dickinson and Company
Microbiology · 26d
Cleared Jun 09, 2015
Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose...
K141292 · NBW
Bionime Coporation
Chemistry · 386d