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
31369–31392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 2016
'cottony' II TAPE, PLEDGETS
K153089 · GAT
Teleflexmedical, Inc.
General & Plastic Surgery · 291d
Cleared Aug 12, 2016
EMS-200
K153285 · EKX
Meta Systems Co., Ltd.
Dental · 274d
Cleared Aug 12, 2016
Perifix and Contiplex Catheter
K153297 · BSO
B.Braun Medical, Inc.
Anesthesiology · 273d
Cleared Aug 12, 2016
EUROIMMUN Anti-West Nile Virus ELISA (IgM)
K153308 · NOP
Euroimmun Us, Inc.
Microbiology · 269d
Cleared Aug 12, 2016
ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators,...
K153375 · MRG
Abbott Laboratories
Chemistry · 263d
Cleared Aug 12, 2016
LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open...
K160331 · GEI
Covidien
General & Plastic Surgery · 186d
Cleared Aug 12, 2016
SUPERCATH 6
K160592 · FOZ
Togo Medikit Co., Ltd.
General Hospital · 164d
Cleared Aug 12, 2016
ECG100+, ECG200+
K160840 · DPS
Cardioline S.P.A
Cardiovascular · 137d
Cleared Aug 12, 2016
RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the...
K161210 · OUR
Medtronic Sofamor Danek
Orthopedic · 106d
Cleared Aug 12, 2016
CELTRA Press
K161269 · EIH
Dentsply Sirona
Dental · 99d
Cleared Aug 12, 2016
Raycell Mk2
K161324 · MOT
Best Theratronics Limited
Radiology · 93d
Cleared Aug 12, 2016
Thermi RF Accessories
K161661 · GEI
Thermi
General & Plastic Surgery · 57d
Cleared Aug 11, 2016
SACCADOMETER PLUS, SACCADOMETER ADVANCED
K152890 · HLL
Ober Consulting Sp. Z.O.O.
Ophthalmic · 316d
Cleared Aug 11, 2016
VivoSight Dx Topical OCT System
K153283 · NQQ
Michelson Diagnostics, Ltd.
General & Plastic Surgery · 273d
Cleared Aug 11, 2016
Salto XT, Salto Talaris
K153452 · HSN
Tornier S.A.S.
Orthopedic · 255d
Cleared Aug 11, 2016
Converge
K153573 · HRS
Biomedical Enterprises, Inc.
Orthopedic · 240d
Cleared Aug 11, 2016
Adhesive Electrodes
K160138 · GXY
Gmdasz Manufacturing Co., Ltd.
Neurology · 203d
Cleared Aug 11, 2016
OT EQUATOR
K160382 · NHA
Rhein 83 Srl
Dental · 183d
Cleared Aug 11, 2016
Athena Breast Pump
K161266 · HGX
Exploramed Nc7, Inc.
Obstetrics & Gynecology · 98d
Cleared Aug 11, 2016
Response BandLoc Spinal Fixation
K161267 · OWI
OrthoPediatrics Corp.
Orthopedic · 98d
Cleared Aug 11, 2016
VSI StraitSet micro-introducer kit
K161336 · DRE
Vascular Solutions, Inc.
Cardiovascular · 90d
Cleared Aug 11, 2016
Discovery MI
K161574 · KPS
Ge Medical Systems, LLC
Radiology · 65d
Cleared Aug 11, 2016
LensGiene Sterile Saline Solution
K161622 · LPN
Optics Laboratory, Inc.
Ophthalmic · 59d
Cleared Aug 11, 2016
Aer-O-Scope Colonoscope System
K161791 · FDF
Gi View , Ltd.
Gastroenterology & Urology · 43d