FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
23977–24000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 2018
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
K182596 · IYN
Canon Medical Systems Corporation
Radiology · 43d
Cleared Nov 02, 2018
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
K182616 · NQQ
Ninepoint Medical, Inc.
General & Plastic Surgery · 42d
Cleared Nov 02, 2018
PRODENSE Bone Graft Substitute
K182823 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Nov 01, 2018
DAEHAN Adhesive Surface Electrodes
K180247 · GXY
Daehan Medical Systems Co., Ltd.
Neurology · 276d
Cleared Nov 01, 2018
DePuy Synthes Trauma Orthopedic Plates and Screws
K180310 · HRS
Synthes (Usa) Products, LLC / Depuy...
Orthopedic · 269d
Cleared Nov 01, 2018
Clear-Tip EUS-FNA
K180363 · FCG
Finemedix Co., Ltd.
Gastroenterology & Urology · 265d
Cleared Nov 01, 2018
Spectra Optia Apheresis System
K181049 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 195d
Cleared Nov 01, 2018
Implantswiss Dental Implant System, Implantswiss Dental Abutment System
K181266 · DZE
Novodent SA
Dental · 171d
Cleared Nov 01, 2018
GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine...
K181273 · NBW
I-Sens, Inc.
Chemistry · 171d
Cleared Nov 01, 2018
Medline Unite Mini Plates and Screws
K181820 · HRS
Medline Industries, Inc.
Orthopedic · 115d
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