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
18769–18792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2020
Aesculap Caiman 5 Seal and Cut Technology System
K202938 · GEI
Aesculap, Inc.
General & Plastic Surgery · 30d
Cleared Oct 30, 2020
eKuore Pro Series
K203007 · DQD
Chip Ideas Electronics S.L.
Cardiovascular · 29d
Cleared Oct 30, 2020
FUJIFILM Distal End Cap
K203028 · FDT
Fujifilm Corporation
Gastroenterology & Urology · 28d
Cleared Oct 29, 2020
MedCAD® AccuPlan® System
K192282 · DZJ
Medcad
Dental · 434d
Cleared Oct 29, 2020
Libertas E-XLPE Modular Liner
K192989 · OQI
Maxx Orthopedics, Inc.
Orthopedic · 370d
Cleared Oct 29, 2020
HCG Zirconia Ceramic Block
K193090 · EIH
Hocheng Corporation
Dental · 358d
Cleared Oct 29, 2020
Nelson Sentinel Series Basic Chlorine Sentinel
K193169 · MSY
Nelson Environmental Technologies, Inc.
Gastroenterology & Urology · 349d
Cleared Oct 29, 2020
WiZARD 510 Nasal Mask
K193206 · BZD
Apex Medical Corp.
Anesthesiology · 344d
Cleared Oct 29, 2020
g.Estim FES
K200088 · IPF
G.Tec Medical Engineering GmbH
Physical Medicine · 288d
Cleared Oct 29, 2020
Curos Jet Disinfecting Cap
K200299 · QBP
3M Company
General Hospital · 266d
Cleared Oct 29, 2020
EXPERT - Joint Fixation System
K200332 · HTN
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 262d
Cleared Oct 29, 2020
Female Luer Lock Cap
K200425 · FPA
Medsafety Solutions, LLC
General Hospital · 252d
Cleared Oct 29, 2020
LSN
K201092 · JAK
Imaging Biometrics, LLC
Radiology · 189d
Cleared Oct 29, 2020
NuVasive Modulus XLIF Interbody System
K201692 · MAX
Nu Vasive, Incorporated
Orthopedic · 129d
Cleared Oct 29, 2020
OsteoMed ExtremiFix Mini & Small System Tray
K202105 · KCT
Osteomed, LLC
General Hospital · 92d
Cleared Oct 29, 2020
Sleepware G3
K202142 · OLZ
Respironics, Inc.
Neurology · 90d
Cleared Oct 29, 2020
ANTHEM Fracture System
K202496 · HRS
Globus Medical, Inc.
Orthopedic · 59d
Cleared Oct 29, 2020
Nutriglide(TM) Nasal Feeding Tube
K202539 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 57d
Cleared Oct 29, 2020
Visera Elite II Video System Center
K202646 · FET
Olympus Medical Systems Corp.
Obstetrics & Gynecology · 48d
Cleared Oct 29, 2020
ARIX Ankle Distal Tibia System
K202912 · HRS
Jeil Medical Corporation
Orthopedic · 30d
Cleared Oct 29, 2020
CONSTRUX Mini PEEK Spacer System
K202949 · ODP
Orthofix, Inc.
Orthopedic · 29d
Cleared Oct 29, 2020
Flexible Video Cysto-Urethroscope (C-view)
K202957 · FAJ
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 29d
Cleared Oct 29, 2020
CloudVue
K203058 · LLZ
International Medical Solutions, Inc.
Radiology · 21d
Cleared Oct 28, 2020
Comprehensive Shoulder System
K193038 · MBF
Biomet Manufacturing Corp
Orthopedic · 363d