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

Filters: Cleared only ×
175,820 results
36433–36456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 2014
ONEFIT HIP PLANNER
K142671 · LLZ
Onefit Medical
Radiology · 77d
Cleared Dec 05, 2014
Siemens 3.0T PROCURE Array Coil
K142676 · MOS
Resonance Innovations, LLC
Radiology · 77d
Cleared Dec 05, 2014
ADVIA Centaur HAV total assay
K142758 · LOL
Siemens Healthcare Diagnostics, Inc.
Microbiology · 71d
Cleared Dec 05, 2014
TOTAL COMPRESSION PLATING SYSTEM
K143025 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 45d
Cleared Dec 05, 2014
ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol...
K143194 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 29d
Cleared Dec 05, 2014
Viscoelastic Injector
K143205 · MRH
Sight Sciences, Inc.
Ophthalmic · 28d
Cleared Dec 05, 2014
Schoelly Laparoscope
K143221 · GCJ
Schoelly Fiberoptic GmbH
General & Plastic Surgery · 25d
Cleared Dec 04, 2014
B TRAVELSAVVY SHARPS CONTAINER
K140285 · MMK
Bellegrove Medical Supply, Inc.
General Hospital · 303d
Cleared Dec 04, 2014
CUROS RED PORT PROTECTOR
K140657 · QBP
Ivera Medical, Inc.
General Hospital · 265d
Cleared Dec 04, 2014
VESOFLOW PLUS DVT COMPRESSION DEVICE
K141064 · JOW
Caremed Supply, Inc.
Cardiovascular · 224d
Cleared Dec 04, 2014
MARK3
K141092 · ELW
Cavex Holland BV
Dental · 220d
Cleared Dec 04, 2014
PULSE OXIMETER
K141105 · DQA
Hunan Accurate Bio-Medical Technology...
Anesthesiology · 219d
Cleared Dec 04, 2014
GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES
K141613 · LYZ
Zibo Goldenline Plastic Product Co.,...
General Hospital · 171d
Cleared Dec 04, 2014
ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM
K141632 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 169d
Cleared Dec 04, 2014
RADAR VASCULAR COMPRESSION DEVICE
K142122 · DXC
Advanced Vascular Dynamics
Cardiovascular · 122d
Cleared Dec 04, 2014
NATURE'S BOND 600 AND NATURE'S BOND 603
K142168 · HGX
Devon Medical Products, Inc.
Obstetrics & Gynecology · 120d
Cleared Dec 04, 2014
ActiveCare+SFT
K142728 · JOW
Medical Compressions System (Dbn) , Ltd.
Cardiovascular · 72d
Cleared Dec 04, 2014
Endovascular Stent Planning Software
K143079 · LLZ
Vital Images, Inc.
Radiology · 38d
Cleared Dec 04, 2014
SafeAir Smoke Pencil
K143145 · GEI
Lina Medical Aps
General & Plastic Surgery · 31d
Cleared Dec 03, 2014
CLEARVIEW
K133373 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 397d
Cleared Dec 03, 2014
X TWIN SYSTEM
K133496 · KPR
Roesys GmbH
Radiology · 384d
Cleared Dec 03, 2014
5000Z FIREFLY SYSTEM
K133502 · NUH
Prizm Medical, Inc.
Neurology · 384d
Cleared Dec 03, 2014
ENDOLUMINAL OCCLUSION SYSTEM (EOS)
K133924 · KRD
Artventive Medical Group, Inc.
Cardiovascular · 345d
Cleared Dec 03, 2014
STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR
K140589 · FRC
Mesa Laboratories, Inc.
General Hospital · 271d