Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
33265–33288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2015
Optilite Hevylite IgM Kappa Kit
K152389 · PDE
The Binding Site Group , Ltd.
Immunology · 116d
Cleared Dec 18, 2015
TOMCAT Cervical Spinal System
K152515 · OVE
Choicespine, LP
Orthopedic · 107d
Cleared Dec 18, 2015
AERO -C Cervical Cage System
K152532 · ODP
Stryker Spine
Orthopedic · 106d
Cleared Dec 18, 2015
Imbibe Needle
K153306 · KNW
Orthovita, Inc.
Gastroenterology & Urology · 32d
Cleared Dec 18, 2015
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
K153365 · JIX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Dec 18, 2015
ST AIA-PACK PROG III Calibrator Set
K153417 · JIT
Tosoh Bioscience, Inc.
Chemistry · 23d
Cleared Dec 18, 2015
EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes,...
K153499 · GEI
Conmed Corporation
General & Plastic Surgery · 11d
Cleared Dec 17, 2015
PRODIGY iConnect Blood Glucose Monitoring System
K142785 · NBW
Ok Biotech Co., Ltd.
Chemistry · 447d
Cleared Dec 17, 2015
Next Science Wound Gel
K150792 · FRO
Next Science, LLC
General & Plastic Surgery · 267d
Cleared Dec 17, 2015
BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb...
K150815 · PMG
Becton, Dickinson and Company
Immunology · 265d
Cleared Dec 17, 2015
Intraluminal Applicator Set
K151022 · JAQ
Varian Medical Systems, Inc.
Radiology · 245d
Cleared Dec 17, 2015
WASTON Metallic Intramedullary Nail System
K151062 · HSB
Changzhou Waston Medical Appliance...
Orthopedic · 241d
Cleared Dec 17, 2015
SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad,...
K151329 · LKD
Sentec AG
Anesthesiology · 213d
Cleared Dec 17, 2015
UV Lamps for Indoor Tanning Devices
K151370 · LEJ
Light Sources, Inc.
General & Plastic Surgery · 210d
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 CT 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