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
29809–29832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 2017
Cercon
K162888 · EIH
Dentsply Sirona
Dental · 130d
Cleared Feb 24, 2017
3NT endoscopy system
K162916 · EOB
3nt Medical , Ltd.
Ear, Nose, Throat · 130d
Cleared Feb 24, 2017
Rusch Simplastic Foley Catheters
K162989 · EZL
Teleflexmedical, Inc.
Gastroenterology & Urology · 120d
Cleared Feb 24, 2017
Revolution™ Spinal Fixation System
K163056 · NKB
Intelligent Implant Systems, LLC
Orthopedic · 115d
Cleared Feb 24, 2017
Renamel NANO +plus
K163480 · EBF
Cosmedent, Inc.
Dental · 74d
Cleared Feb 24, 2017
Arrow Endurance Extended Dwell Peripheral Catheter System
K163513 · FOZ
Arrow International, Inc. (Subsidiary...
General Hospital · 71d
Cleared Feb 24, 2017
Vesco Medical NRFit Tip Syringes
K170218 · FMF
Vesco Medical, LLC
General Hospital · 30d
Cleared Feb 24, 2017
Sydney IVF Culture Oil
K170257 · MQL
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 28d
Cleared Feb 23, 2017
MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM
K160837 · BWF
Medinet Srl
Anesthesiology · 335d
Cleared Feb 23, 2017
Powder Free Nitrile Examination Gloves, Black
K161099 · LZA
Pt. Maja Agung Latexindo
General Hospital · 310d
Cleared Feb 23, 2017
George King Coumadin Plasma
K161316 · GGN
George King Bio-Medical, Inc.
Hematology · 288d
Cleared Feb 23, 2017
Dual Top Screw System
K161335 · OAT
Jeil Medical Corporation
Dental · 287d
Cleared Feb 23, 2017
VISULUX
K161607 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 258d
Cleared Feb 23, 2017
Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis
K161693 · NLQ
Stryker Sustainability Solutions
General & Plastic Surgery · 248d
Cleared Feb 23, 2017
Family of Steam sterilizers B17 B22 Series
K161848 · FLE
Cefla S.C.
General Hospital · 233d
Cleared Feb 23, 2017
Pressure Therapy System
K161907 · IRP
Xiamen Senyang Co., Ltd.
Physical Medicine · 226d
Cleared Feb 23, 2017
Lung Nodule Assessment and Comparison Option (LNA)
K162484 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 169d
Cleared Feb 23, 2017
RSM 1824C with RConsole1
K162670 · MUE
DRTECH Corporation
Radiology · 150d
Cleared Feb 23, 2017
VIDAS B.R.A.H.M.S. PCT (PCT)
K162827 · PRI
bioMerieux, Inc.
Microbiology · 139d
Cleared Feb 23, 2017
Reveal LINQ
K162855 · MXD
Medtronic, Inc.
Cardiovascular · 134d
Cleared Feb 23, 2017
GalaFORM 3D
K162922 · OOD
Tepha, Inc.
General & Plastic Surgery · 128d
Cleared Feb 23, 2017
Air-Powered Handpieces and Handpiece Attachments
K162926 · EFB
W&H Dentalwerk Burmoos GmbH
Dental · 127d
Cleared Feb 23, 2017
Stryker OrthoMap Versatile Hip System
K162937 · OLO
Stryker Corporation
Orthopedic · 126d
Cleared Feb 23, 2017
Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl...
K163168 · LYZ
Hebei Hongtai Plastic Products...
General Hospital · 101d