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
20665–20688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 2020
Ezfil
K191991 · EBF
Meta Biomed Co., Ltd.
Dental · 224d
Cleared Mar 05, 2020
CURA 778
K192590 · JAK
Fmi Medical Systems, Inc.
Radiology · 167d
Cleared Mar 05, 2020
Instinct Plus Endoscopic Clipping Device
K192697 · PKL
Cook Endoscopy
Gastroenterology & Urology · 161d
Cleared Mar 05, 2020
Lucent : IPL
K193072 · ONF
Luvo Medical Technologies, Inc.
General & Plastic Surgery · 122d
Cleared Mar 05, 2020
Omnifix Low Dead Space Luer Lock Syringe
K193101 · FMF
B.Braun Medical, Inc.
General Hospital · 118d
Cleared Mar 05, 2020
ProVecta 3D Prime Ceph
K193139 · OAS
Durr Dental SE
Radiology · 113d
Cleared Mar 05, 2020
Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
K193147 · PJB
Stereotaxis, Inc.
Cardiovascular · 113d
Cleared Mar 05, 2020
Transpara
K193229 · QDQ
Screenpoint Medical B.V.
Radiology · 104d
Cleared Mar 05, 2020
ALLthread PEEK Suture Anchor
K193402 · MBI
Biomet, Inc.
Orthopedic · 90d
Cleared Mar 05, 2020
ATLANTIS Abutment for MIS Conical Connection Implants
K193529 · NHA
Dentsply Sirona
Dental · 76d
Cleared Mar 05, 2020
TrackX
K200360 · OWB
Track X Technology, LLC
Radiology · 21d
Cleared Mar 04, 2020
Lubrina 2
K190509 · EFB
J. Morita USA, Inc.
Dental · 369d
Cleared Mar 04, 2020
KinematX Total Wrist Arthroplasty System
K191525 · JWJ
Extremity Medical, LLC
Orthopedic · 268d
Cleared Mar 04, 2020
Broncholab
K191550 · JAK
Fluidda, Inc.
Radiology · 266d
Cleared Mar 04, 2020
Mecta-C Stand Alone
K192906 · OVE
Medacta International S.A.
Orthopedic · 141d
Cleared Mar 04, 2020
DANNIK Disposable Monopolar Laparoscopic Instrument
K193019 · GEI
Dannik
General & Plastic Surgery · 127d
Cleared Mar 04, 2020
TumEase Acupressure Bracelets
K193374 · MVV
Mumease
Neurology · 90d
Cleared Mar 04, 2020
Vista Clear
K193389 · MVL
Inter-Med/Vista Dental Products
Dental · 89d
Cleared Mar 04, 2020
ARIX Ankle System
K193616 · HRS
Jeil Medical Corporation
Orthopedic · 69d
Cleared Mar 04, 2020
Coronet Soft Tissue Fixation System
K200028 · MBI
Conextions Medical
Orthopedic · 58d
Cleared Mar 04, 2020
L100 Go System
K200262 · GZI
Bioness, Inc.
Neurology · 30d
Cleared Mar 04, 2020
Sapphire II PRO
K200269 · LOX
Orbusneich Medical Trading, Inc.
Cardiovascular · 29d
Cleared Mar 04, 2020
Capere Thrombectomy System
K200314 · QEW
Vascular Medcure, Inc.
Cardiovascular · 27d
Cleared Mar 03, 2020
Fixone Biocomposite Small Anchor
K192032 · MAI
Aju Pharm Co., Ltd.
Orthopedic · 217d