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
34705–34728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 2015
Zimmer Patient-Specific Abutment, Internal Hex, Titanium
K143505 · NHA
Zimmer Dental, Inc.
Dental · 197d
Cleared Jun 25, 2015
Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular...
K143604 · DQO
Alvimedica Tibbi Urunler Sanayi VE...
Cardiovascular · 189d
Cleared Jun 25, 2015
Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider
K150538 · NUJ
Stryker Sustainability Solutions
General & Plastic Surgery · 114d
Cleared Jun 25, 2015
aeris Balloon Dialation Catheter
K150951 · KTI
Bryan Medical, Inc.
Ear, Nose, Throat · 77d
Cleared Jun 25, 2015
Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and...
K150975 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 73d
Cleared Jun 25, 2015
ALIF Interfixated System
K151214 · OVD
Nu Vasive, Incorporated
Orthopedic · 50d
Cleared Jun 25, 2015
K-Pack II Needle - 29G x 5/16 Thin Wall
K151398 · FMI
Terumo Europe N.V.
General Hospital · 30d
Cleared Jun 25, 2015
GSI TympStar Pro Middle Ear Analyzer
K151509 · ETY
Diagnostic Group, Dba Grason-Stadler
Ear, Nose, Throat · 21d
Cleared Jun 24, 2015
MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX
K120577 · BZG
Medikro OY
Anesthesiology · 1213d
Cleared Jun 24, 2015
Plus Surgical Gowns (EO Sterilized), PMGB-XXX
K133075 · FYA
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 632d
Cleared Jun 24, 2015
Plus Surgical Drapes (EO Sterilized), PMDB-XXX
K133080 · KKX
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 632d
Cleared Jun 24, 2015
0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)
K143093 · LIT
Hotspur Technologies, Inc.,
Cardiovascular · 239d
Cleared Jun 24, 2015
GALAXY MIS Screw System
K143110 · NKB
Bm Korea
Orthopedic · 238d
Cleared Jun 24, 2015
Habib EUS RFA
K150029 · GEI
Emcision , Ltd.
General & Plastic Surgery · 167d
Cleared Jun 24, 2015
STALIF C
K150053 · OVE
Centinel Spine, Inc.
Orthopedic · 163d
Cleared Jun 24, 2015
Carestream DRX-1 System
K150766 · MQB
Carestream Health, Inc.
Radiology · 92d
Cleared Jun 24, 2015
Virage OCT Spinal Fixation System
K151031 · NKG
Zimmer Spine, Inc.
Orthopedic · 68d
Cleared Jun 24, 2015
VICTUS Femtosecond Laser Platform
K151161 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 54d
Cleared Jun 24, 2015
VariAx 2 Wrist Fusion System
K151178 · HRS
Stryker Trauma AG
Orthopedic · 51d
Cleared Jun 24, 2015
Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver...
K151387 · HBW
Stryker
Neurology · 29d
Cleared Jun 23, 2015
MIDSLEEVE
K142548 · KNT
Medical Innovation Development
Gastroenterology & Urology · 286d
Cleared Jun 23, 2015
Ontex Unscented Tampons with Colored Plastic Applicators
K142786 · HEB
Ontex Bvba
Obstetrics & Gynecology · 270d
Cleared Jun 23, 2015
DiscoverEEG System, Model DE-401
K142834 · OLT
Neurowave Systems, Inc.
Neurology · 266d
Cleared Jun 23, 2015
Merits Yoga Power Scooter, S542
K142912 · INI
Merits Health Products Co., Ltd.
Physical Medicine · 260d