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
34249–34272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 2015
ManipulatOR PRO, ManipulatOR
K150519 · LKF
Gynetech Pty. , Ltd.
Obstetrics & Gynecology · 170d
Cleared Aug 19, 2015
ScandiDos Delta4 Phantom+
K151180 · IYE
Scandidos AB
Radiology · 107d
Cleared Aug 19, 2015
Corporate Dental Imaging (CDI) Application
K151371 · LLZ
U.S. Army Dental Command (Dencom)
Radiology · 90d
Cleared Aug 19, 2015
CS 3D Imaging
K151837 · LLZ
Trophy
Radiology · 44d
Cleared Aug 19, 2015
TraceIT Tissue Marker - 3mL
K151998 · NEU
Augmenix, Inc.
General & Plastic Surgery · 30d
Cleared Aug 19, 2015
Cook ECM Powder
K152033 · KGN
Cook Biotech Incorporated
General & Plastic Surgery · 28d
Cleared Aug 19, 2015
FUJIFILM SonoSite X-Porte Ultrasound System
K152209 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 12d
Cleared Aug 18, 2015
NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND...
K143289 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 274d
Cleared Aug 18, 2015
SterilContainer S
K143729 · KCT
Aesculap, Inc.
General Hospital · 232d
Cleared Aug 18, 2015
Full Automatic (NIBP)Blood Pressure Monitor
K150311 · DXN
Health & Life Co., Ltd.
Cardiovascular · 190d
Cleared Aug 18, 2015
OsteoSelect PLUS Demineralized Bone Matrix Putty
K150621 · MQV
Bacterin International, Inc.
Orthopedic · 160d
Cleared Aug 18, 2015
Nexus Suture
K151009 · GAT
Baylis Medical Company, Inc.
General & Plastic Surgery · 125d
Cleared Aug 18, 2015
LnK Lumbar Interbody Fusion Cage System
K151140 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 111d
Cleared Aug 18, 2015
Instru-Safe Instrument Protection System
K151166 · KCT
Summit Medical, Inc.
General Hospital · 109d
Cleared Aug 18, 2015
Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen...
K151348 · LFG
Healgen Scientific, LLC
Toxicology · 90d
Cleared Aug 18, 2015
Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components
K151463 · DRA
Hansen Medical, Inc.
Cardiovascular · 78d
Cleared Aug 18, 2015
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
K151961 · HJK
Volk Optical, Inc.
Ophthalmic · 33d
Cleared Aug 17, 2015
SOPIX
K142995 · MUH
Sopro - Acteon Group
Radiology · 305d
Cleared Aug 17, 2015
EDOSE
K150767 · IYE
Guangzhou Raydose Software...
Radiology · 146d
Cleared Aug 17, 2015
Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
K150986 · MML
Meddev Corporation
Ophthalmic · 125d
Cleared Aug 17, 2015
Nexus Universal, Nexus Universal Chroma
K151332 · EMA
Sybron Dental Specialties
Dental · 90d
Cleared Aug 17, 2015
VesselNavigator Rel. 1.0
K151598 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 66d
Cleared Aug 14, 2015
MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
K143538 · DXT
Bayer Medical Care, Inc.
Cardiovascular · 242d
Cleared Aug 14, 2015
PaxWire Occlusion Balloon System
K143613 · MJN
Accessclosure, Inc.
Cardiovascular · 238d