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
34657–34680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 2015
CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System
K150873 · IYE
Accuray Incorporated
Radiology · 91d
Cleared Jul 01, 2015
Suture Wires and Wire Loops
K150889 · JDQ
Zimmer, Inc.
Orthopedic · 90d
Cleared Jul 01, 2015
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
K150901 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 89d
Cleared Jul 01, 2015
STARband, STARlight
K151147 · OAN
Orthomerica Products, Inc.
Neurology · 62d
Cleared Jul 01, 2015
Wondfo CR3 Keyless Split Sample Cup
K151478 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared Jul 01, 2015
EN Snare Endovascular Snare System
K151497 · MMX
Merit Medical Systems, Inc.
Cardiovascular · 27d
Cleared Jun 30, 2015
AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate...
K141680 · HRS
Auxein Medical
Orthopedic · 372d
Cleared Jun 30, 2015
Vitalograph Model 6600 Compact
K142642 · BZG
Vitalograph (Ireland) , Ltd.
Anesthesiology · 286d
Cleared Jun 30, 2015
Artemis Hand Held Imaging System
K143474 · OWN
Quest Medical Imaging
General & Plastic Surgery · 207d
Cleared Jun 30, 2015
V60 Anesthetic Vaporizer
K150167 · CAD
Shenzhen Mindray Bio-Medical...
Anesthesiology · 155d
Cleared Jun 30, 2015
COMPASS
K150320 · MYC
Centervue S.P.A.
Ophthalmic · 141d
Cleared Jun 30, 2015
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
K150445 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 130d
Cleared Jun 30, 2015
Sensis
K150493 · DQK
Siemens Medi Cal Solutions, Inc.
Cardiovascular · 125d
Cleared Jun 30, 2015
Modular Power Positioning System
K150574 · ITI
Motion Concepts
Physical Medicine · 116d
Cleared Jun 30, 2015
Besmed Reusable Jet Nebulizer
K150591 · CAF
Besmed Health Business Corp
Anesthesiology · 113d
Cleared Jun 30, 2015
Lineum OCT Spine System
K151224 · NKG
Biomet Spine
Orthopedic · 54d
Cleared Jun 30, 2015
Aneroid Sphygmomanometer
K151246 · DXQ
Jiaxing Zhongfa Medical Products Co.,...
Cardiovascular · 50d
Cleared Jun 30, 2015
AGE Automatic Wrist Blood Pressure Monitor
K151281 · DXN
Dongguan Ageless Health Industrial...
Cardiovascular · 47d
Cleared Jun 30, 2015
Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff
K151290 · DXQ
Xuzhou Maicuff Technology Co., Ltd.
Cardiovascular · 46d
Cleared Jun 30, 2015
The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the...
K151331 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 42d
Cleared Jun 30, 2015
GENESIS
K151485 · JAA
Dornier Medtech America, Inc.
Radiology · 28d
Cleared Jun 29, 2015
Vitalograph Model 6800 Pneumotrac
K142812 · BZG
Vitalograph (Ireland) , Ltd.
Anesthesiology · 273d
Cleared Jun 29, 2015
TRAUS ENDO
K143411 · EKX
Saeshin Precision Co., Ltd.
Dental · 213d
Cleared Jun 29, 2015
BioZorb Marker
K143484 · NEU
Focal Therapeutics
General & Plastic Surgery · 203d