FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
26089–26112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 2018
GSI Viewer with GSI Fat Option
K180225 · JAK
GE Medical Systems SCS
Radiology · 88d
Cleared Apr 24, 2018
Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank
K180252 · EIH
Crown Porcelain Dental Technology...
Dental · 84d
Cleared Apr 24, 2018
Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
K180277 · OLO
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Apr 23, 2018
Sysmex UF-5000 Fully Automated Urine Particle Analyzer
K171883 · LKM
Sysmex America, Inc.
Hematology · 304d
Cleared Apr 23, 2018
Frova Intubating Introducer
K171917 · BTR
Cook Incorporated
Anesthesiology · 300d
Cleared Apr 23, 2018
Patient Status Engine
K172329 · DRG
Isansys Lifecare, Ltd.
Cardiovascular · 264d
Cleared Apr 23, 2018
Advisor HD Grid Mapping Catheter, Sensor Enabled
K172393 · MTD
St. Jude Medical, Inc.
Cardiovascular · 258d
Cleared Apr 23, 2018
EnSite Velocity Cardiac Mapping System v5.2
K172396 · DQK
St Jude Medical
Cardiovascular · 258d
Cleared Apr 23, 2018
Agile Nail
K172699 · HSB
Orthofix Srl
Orthopedic · 228d
Cleared Apr 23, 2018
3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5...
K173519 · FRC
3M Company
General Hospital · 160d
Cleared Apr 23, 2018
AlertWatch:OB
K173715 · HGM
Alertwatch, Inc.
Obstetrics & Gynecology · 140d
Cleared Apr 23, 2018
da Vinci Xi Surgical System, da Vinci X Surgical System
K173842 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 126d
Cleared Apr 23, 2018
Cure™ Lumbar Plate System
K180090 · KWQ
Meditech Spine, LLC
Orthopedic · 101d
Cleared Apr 23, 2018
Reprocessed LigaSure Maryland Jaw Sealer/Divider
K180499 · NUJ
Stryker Sustainability Solutions
General & Plastic Surgery · 56d
Cleared Apr 20, 2018
Etherea MX
K171443 · GEX
Vydence Medical Industria E Comercio...
General & Plastic Surgery · 339d
Cleared Apr 20, 2018
EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
K172244 · KTL
Euroimmun Us, Inc.
Immunology · 268d
Cleared Apr 20, 2018
EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
K172252 · KTL
Euroimmun Us, Inc.
Immunology · 268d
Cleared Apr 20, 2018
Hickman TriFusion Catheter
K172511 · LJS
C.R. Bard, Inc.
General Hospital · 242d
Cleared Apr 20, 2018
Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use...
K173258 · KGO
Pt. Medisafe Technologies
General Hospital · 192d
Cleared Apr 20, 2018
Sharpsite AC Rigid Endsocope
K173855 · EOB
Medtronic Xomed, Inc.
Ear, Nose, Throat · 121d
Cleared Apr 20, 2018
Arthrex Univers Revers Modular Glenoid System
K173900 · PHX
Arthrex, Inc.
Orthopedic · 119d
Cleared Apr 20, 2018
Neodent Implant System – GM Line
K173902 · NHA
Jjgc Industria E Comercio DE...
Dental · 119d
Cleared Apr 20, 2018
Viamo c100 TUS-VC100 Diagnostic Ultrasound System
K173962 · IYN
Toshibamedical Systems Corporation
Radiology · 113d
Cleared Apr 20, 2018
ProFlex Laser Fibers
K180140 · GEX
Innovaquartz, LLC
General & Plastic Surgery · 92d