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
24577–24600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 2018
N Latex FLC kappa assay, N Latex FLC lambda assay
K182098 · DFH
Siemens Healthcare Diagnostics...
Immunology · 90d
Cleared Nov 01, 2018
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD...
K182273 · DXT
Bayer Medical Care, Inc.
Cardiovascular · 71d
Cleared Nov 01, 2018
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
K182276 · DXT
Bayer Medical Care, Inc.
Cardiovascular · 71d
Cleared Nov 01, 2018
Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens
K182523 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 49d
Cleared Oct 31, 2018
AVIEW
K171199 · LLZ
Coreline Soft Co., Ltd.
Radiology · 555d
Cleared Oct 31, 2018
LUXEN Zr, LUXEN Smile
K171585 · EIH
Dentalmax Co., Ltd.
Dental · 518d
Cleared Oct 31, 2018
Panpac Flexi Shelf Pessary
K173351 · HHW
Panpac Medical Corporation
Obstetrics & Gynecology · 371d
Cleared Oct 31, 2018
Endomat Select
K180735 · HIG
Karl Storz SE & CO. KG
Obstetrics & Gynecology · 223d
Cleared Oct 31, 2018
Universal Base Abutment
K180899 · NHA
Nobel Biocare AB
Dental · 208d
Cleared Oct 31, 2018
Immunalysis Ethyl Alcohol Enzyme Assay
K181553 · DIC
Immunalysis Corporation
Toxicology · 140d
Cleared Oct 31, 2018
Single Use Aspiration Needle NA-U201H
K181994 · FCG
Olympus Medical Systems Corp.
Gastroenterology & Urology · 97d
Cleared Oct 31, 2018
Tumark for Eviva, Tumark for Brevera
K182082 · NEU
Somatex Medical Technologies GmbH
General & Plastic Surgery · 90d
Cleared Oct 31, 2018
Balanced Knee Revision System Trabecular Tibial Cone Augments
K182085 · JWH
Ortho Development Corporation
Orthopedic · 90d
Cleared Oct 31, 2018
DynaMesh-POSTERIOR
K182087 · FTL
Feg Textiltechnik Forschungs- Und...
General & Plastic Surgery · 90d
Cleared Oct 31, 2018
XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro
K182088 · GEX
Fotona D.O.O.
General & Plastic Surgery · 90d
Cleared Oct 31, 2018
Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
K182588 · NUJ
Surgical Instrument Service and...
General & Plastic Surgery · 41d
Cleared Oct 31, 2018
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1
K182679 · IYN
Canon Medical Systems Corporation
Radiology · 35d
Cleared Oct 31, 2018
Halifax Imaging Kit
K182880 · KPR
Halifax Biomedical, Inc.
Radiology · 16d
Cleared Oct 30, 2018
UroGen Ureteral Catheter
K180354 · KOD
Urogen Pharma, Ltd.
Gastroenterology & Urology · 264d
Cleared Oct 30, 2018
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
K180718 · DYW
Tomy, Inc.
Dental · 225d
Cleared Oct 30, 2018
LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier
K181488 · FZP
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 146d
Cleared Oct 30, 2018
Cios Spin
K181550 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 139d
Cleared Oct 30, 2018
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
K182062 · JOY
Sysmex America, Inc.
Hematology · 90d
Cleared Oct 30, 2018
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides,...
K182063 · JFY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 90d