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
32689–32712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2015
Bpump Blood Pressure Cuff
K151810 · DXQ
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 168d
Cleared Dec 17, 2015
Renew NCP-5 External Counterpulsation System
K152115 · DRN
Stage 2 Innovations
Cardiovascular · 141d
Cleared Dec 17, 2015
ARCHITECT 2nd Generation Testosterone
K152155 · CDZ
Abbott Laboratories
Chemistry · 136d
Cleared Dec 17, 2015
PK AIM
K152219 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 132d
Cleared Dec 17, 2015
Sterisheet Sterilization Wrap
K152291 · FRG
Andersen Sterilizers, Inc.
General Hospital · 126d
Cleared Dec 17, 2015
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files,...
K152386 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 115d
Cleared Dec 17, 2015
Freestyle Freedom Blood Glucose Monitoring Sytem
K152442 · NBW
Abbott Laboratories
Chemistry · 112d
Cleared Dec 17, 2015
MoMe Software Platform
K152491 · DSI
Infobionic, Inc.
Cardiovascular · 107d
Cleared Dec 17, 2015
Laser Dock
K152636 · GEX
Patient Pocket, LLC
General & Plastic Surgery · 93d
Cleared Dec 17, 2015
NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible...
K152857 · PNR
Neomed, Inc.
Gastroenterology & Urology · 78d
Cleared Dec 17, 2015
Molteno3 Glaucoma Implant
K152996 · KYF
Innovative Ophthalmic Products, Inc....
Ophthalmic · 65d
Cleared Dec 17, 2015
Beacon Tissue Marker (SE)
K153189 · NEU
Scion Medical Technologies, LLC
General & Plastic Surgery · 44d
Cleared Dec 17, 2015
Klassic Knee System
K153310 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 30d
Cleared Dec 17, 2015
Asahi REXEED-S Series Dialyzer
K153344 · KDI
Asahi Kasei Medical Co., Ltd.
Gastroenterology & Urology · 28d
Cleared Dec 16, 2015
Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue...
K150524 · NLQ
Surgical Instrument Services and...
General & Plastic Surgery · 289d
Cleared Dec 16, 2015
PulseFlowDF
K150806 · JOW
Pulseflow Technologies
Cardiovascular · 265d
Cleared Dec 16, 2015
XM-01 Electronic Automatic Blood Pressure Monitor
K150908 · DXN
Sky Innovation Technology ( Shanghai)...
Cardiovascular · 257d
Cleared Dec 16, 2015
Vios Monitoring System
K150992 · DRT
Vios Medical, Inc.
Cardiovascular · 245d
Cleared Dec 16, 2015
Counter OTC TENS Device, Model CSD-737Z
K151279 · NUH
Counter Scientific Development (Gz),...
Neurology · 216d
Cleared Dec 16, 2015
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire,...
K151840 · DQX
Boston Scientific Corporation
Cardiovascular · 163d
Cleared Dec 16, 2015
Zenostar MT, Zenostar Color Liquids
K152118 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 139d
Cleared Dec 16, 2015
Resolve 2.0
K152322 · PME
Denali Corporation
Dental · 121d
Cleared Dec 16, 2015
AquaShield system CO2, AquaShield system-PENTAX
K153362 · FEQ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 26d
Cleared Dec 16, 2015
Advanced Perfusion System 1
K153376 · DTQ
Terumo Cardiovascular Systems...
Cardiovascular · 23d