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

Filters: Cleared only ×
175,820 results
19129–19152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 2020
Marathon Flow Directed Micro Catheter
K202318 · KRA
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 28d
Cleared Sep 12, 2020
Disposable Enteral Feeding Syringe with Enfit Connector
K193657 · PNR
Shinva Ande Healthcare Apparatus Co.,...
Gastroenterology & Urology · 257d
Cleared Sep 11, 2020
TK Insulin Syringe with/without Saftey Retractable Device
K191639 · MEG
Anhui Tiankang Medical Technology...
General Hospital · 450d
Cleared Sep 11, 2020
IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
K192137 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 401d
Cleared Sep 11, 2020
GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose...
K193340 · NBW
Microtech Medical, Inc.
Chemistry · 284d
Cleared Sep 11, 2020
Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model...
K193449 · HGX
Guangdong Horigen Mother & Baby...
Obstetrics & Gynecology · 273d
Cleared Sep 11, 2020
AMICUS Separator System
K200530 · GKT
Fresenius Kabi AG
Gastroenterology & Urology · 193d
Cleared Sep 11, 2020
DePuy PINNACLE Dual Mobility Liner
K200854 · LPH
Depuy Ireland UC
Orthopedic · 164d
Cleared CT Sep 11, 2020
Fitbit ECG App
K200948 · QDA
Fitbit, Inc.
Cardiovascular · 156d
Cleared Sep 11, 2020
PERFORM Humeral System – Stem
K201315 · PAO
Tornier, Inc.
Orthopedic · 116d
Cleared Sep 11, 2020
SABER .035 PTA Dilatation Catheter
K201333 · LIT
Cordis Corporation
Cardiovascular · 115d
Cleared Sep 11, 2020
Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical...
K201506 · ODP
Meditech Spine, LLC
Orthopedic · 98d
Cleared Sep 11, 2020
PF4 Enhanced assay
K201570 · LCO
Immucor Gti Diagnostics, Inc.
Hematology · 92d
Cleared Sep 11, 2020
HotDog Temperature Management Controller
K201779 · DWJ
Augustine Temperature Management
Cardiovascular · 73d
Cleared Sep 11, 2020
Porcine Mineral Collagen Composite Moldable
K201859 · NPM
Collagen Matrix, Inc.
Dental · 67d
Cleared Sep 11, 2020
DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
K201959 · HRS
DePuy Synthes
Orthopedic · 59d
Cleared Sep 11, 2020
Dynex Micro
K202143 · KTT
Vilex, LLC
Orthopedic · 42d
Cleared Sep 11, 2020
FLEX Vessel Prep System
K202187 · PNO
Venturemed Group, Inc.
Cardiovascular · 38d
Cleared Sep 11, 2020
Aline Ablation Intelligence
K202297 · LLZ
Mirada Medical, Ltd.
Radiology · 29d
Cleared Sep 10, 2020
DSM Biomedical Dental Bone Graft Plus
K193212 · NPM
Dsm Biomedical
Dental · 294d
Cleared Sep 10, 2020
RGK Daily Range Wheelchairs
K200135 · IOR
Rgk Wheelchairs, Ltd.
Physical Medicine · 233d
Cleared Sep 10, 2020
Navigation Module of the Momentum System
K200845 · OLO
Ulrich Medical USA
Orthopedic · 163d
Cleared Sep 10, 2020
X-Pac Expandable Lumbar Cage System
K201145 · MAX
Expanding Innovations, Inc.
Orthopedic · 134d
Cleared Sep 10, 2020
Tigereye CTO-Crossing Catheter
K201330 · PDU
Avinger, Inc.
Cardiovascular · 114d