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
23233–23256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 2019
Disposable Standard Clamp
K190788 · GCJ
Standard Bariatrics
General & Plastic Surgery · 22d
Cleared Apr 17, 2019
eMurmur ID
K181988 · DQD
Csd Labs GmbH
Cardiovascular · 266d
Cleared Apr 17, 2019
SEKURE Creatine Kinase Assay
K182702 · CGS
Sekisui Diagnostics P.E.I., Inc.
Chemistry · 202d
Cleared Apr 17, 2019
Dr. Amplatz Micro Plug
K182944 · KRD
Ka Medical, LLC
Cardiovascular · 176d
Cleared Apr 17, 2019
Andorate Auxiliary Water Connector
K182998 · OCX
Smartdata Suzhou Co., Ltd.
Gastroenterology & Urology · 169d
Cleared Apr 17, 2019
0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion...
K183043 · NRY
Imperative Care, Inc.
Neurology · 166d
Cleared CT Apr 17, 2019
Phoenix
K183152 · PHL
Us Bionics, Inc. (Dba Suitx)
Physical Medicine · 154d
Cleared Apr 17, 2019
Ultra OTC Facial Toning System
K183189 · NFO
Micro Current Technology, Inc.
Physical Medicine · 149d
Cleared Apr 17, 2019
Arthrex 2.5 mm Tenodesis Screw
K183395 · HWC
Arthrex, Inc.
Orthopedic · 131d
Cleared Apr 17, 2019
JETi 88 Peripheral Thrombectomy System
K183403 · QEZ
Walk Vascular, LLC
Cardiovascular · 131d
Cleared Apr 17, 2019
JO H2O Jelly Original Personal Lubricant
K183584 · NUC
United Consortium
Obstetrics & Gynecology · 117d
Cleared Apr 17, 2019
Stasis Monitoring System
K183634 · MWI
Stasis Labs, Inc.
Cardiovascular · 112d
Cleared Apr 17, 2019
SmartLinx Vitals Plus Patient Monitoring System
K183638 · MWI
Capsule Technologie
Cardiovascular · 112d
Cleared Apr 17, 2019
Straumann BLX Variobase Abutment
K190082 · NHA
Institut Straumann AG
Dental · 90d
Cleared Apr 17, 2019
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
K190088 · DHR
Inova Diagnostics, Inc.
Immunology · 90d
Cleared Apr 17, 2019
M-Y Sheath
K190369 · DYB
Ram Medical Innovations, Inc.
Cardiovascular · 61d
Cleared Apr 17, 2019
VersaCross Steerable Sheath, VersaCross Transseptal Dilator
K190688 · DYB
Baylis Medical Company, Inc.
Cardiovascular · 30d
Cleared Apr 17, 2019
HEM-6410T-ZL Wrist Blood Pressure Monitor
K190693 · DXN
Omron Healthcare, Inc.
Cardiovascular · 30d
Cleared Apr 17, 2019
Arthrex SwiveLock Anchors
K190728 · MBI
Arthrex, Inc.
Orthopedic · 27d
Cleared Apr 16, 2019
Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native...
K181541 · MWI
Andon Health Co, Ltd.
Cardiovascular · 309d
Cleared Apr 16, 2019
Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers...
K182217 · GDW
Ezisurg (Suzhou) Medical Co., Ltd.
General & Plastic Surgery · 244d
Cleared Apr 16, 2019
MIST IC
K182246 · NHA
Imagine Milling Technologies, LLC
Dental · 239d
Cleared Apr 16, 2019
General Cutting Contra Handpiece
K182999 · EGS
Nakanishi, Inc.
Dental · 168d
Cleared Apr 16, 2019
KY Banksy Aloe
K183302 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 140d