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
48961–48984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 2010
INTEGRA ELECTRODE TUNNELING NEEDLE
K102802 · GYC
Integra LifeSciences Corporation
Neurology · 57d
Cleared Nov 23, 2010
ACCULMAING
K102849 · LLZ
Radiology Information Systems, Inc.
Radiology · 55d
Cleared Nov 23, 2010
ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL
K102904 · JJX
Siemens Healthcare Diagnostics
Chemistry · 53d
Cleared Nov 23, 2010
PREASSEMBLED SURGICAL WASH SET
K103202 · CAC
Sorin Group Italia S.R.L.
Anesthesiology · 22d
Cleared Nov 23, 2010
OMNI EXPRESS
K103268 · MWI
Infinium Medical
Cardiovascular · 19d
Cleared Nov 23, 2010
PATCHASSIST LARGE
K103269 · ORQ
Polytouch Medical, Ltd.
General & Plastic Surgery · 19d
Cleared Nov 22, 2010
CSTS SCREW
K093055 · HWC
Orthopro, LLC
Orthopedic · 418d
Cleared Nov 22, 2010
HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)
K101547 · FMF
Henke-Sass, Wolf GmbH
General Hospital · 172d
Cleared Nov 22, 2010
AIDI DENTAL IMPLANT SYSTEM
K101755 · DZE
Aidi Biomedical, LLC
Dental · 152d
Cleared Nov 22, 2010
LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2,...
K101817 · GEX
Fotona D.D.
General & Plastic Surgery · 145d
Cleared Nov 22, 2010
MEDRANGE ELECTROSURGICAL GENERATOR
K102114 · GEI
Medrange Corporation
General & Plastic Surgery · 117d
Cleared Nov 22, 2010
SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428
K102122 · KCT
Smith & Nephew, Inc.
General Hospital · 116d
Cleared Nov 22, 2010
SYSTEM 1E CHEMICAL INDICATOR
K102217 · JOJ
STERIS Corporation
General Hospital · 108d
Cleared Nov 22, 2010
SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS
K102308 · DZE
Dentium Co., Ltd.
Dental · 98d
Cleared Nov 22, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102444 · LYZ
Zibo Yingbo Medical Products, Inc.
General Hospital · 88d
Cleared Nov 22, 2010
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX
K102519 · FGE
Flexible Stenting Solutions, Inc.
Gastroenterology & Urology · 81d
Cleared Nov 22, 2010
POWDERFREE BLACK NITRILE EXAMINATION GLOVES
K102620 · LZA
Pt. Medisafe Technologies
General Hospital · 70d
Cleared Nov 22, 2010
SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT
K103104 · KWS
Howmedica Osteonics Corp.
Orthopedic · 33d
Cleared Nov 22, 2010
ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY
K103263 · GDW
Covidien, Formerly US Surgical A...
General & Plastic Surgery · 18d
Cleared Nov 19, 2010
20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A)
K092728 · LLZ
Totoku Electric Co., Ltd.
Radiology · 441d
Cleared Nov 19, 2010
VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE,...
K092745 · KCT
STERIS Corporation
General Hospital · 437d
Cleared Nov 19, 2010
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
K093495 · HLJ
American Diagnostic Corp.
Ophthalmic · 374d
Cleared Nov 19, 2010
NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR...
K094016 · KKX
Hinson and Hale Medical Technologies,...
General Hospital · 325d
Cleared Nov 19, 2010
SLEEP APP
K100185 · LRK
Sleep Medicine Network, Inc.
Dental · 301d