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

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175,820 results
31009–31032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 2016
Flowable Wound Matrix
K160136 · KGN
Cook Biotech Incorporated
General & Plastic Surgery · 252d
Cleared Sep 28, 2016
BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood...
K160365 · NBW
Infopia Co, Ltd.
Chemistry · 232d
Cleared Sep 28, 2016
Aprima Smartesis Centesis Pump
K161002 · BTA
Cook Incorporated
General & Plastic Surgery · 170d
Cleared Sep 28, 2016
NuVasive® Reline® System
K161014 · NKB
Nu Vasive, Incorporated
Orthopedic · 170d
Cleared Sep 28, 2016
Avenue® T TLIF Cage
K161173 · OVD
Ldr Spine USA, Inc.
Orthopedic · 155d
Cleared Sep 28, 2016
NuVasive® CoRoent® Small Interlock™ System
K161442 · OVE
Nu Vasive, Incorporated
Orthopedic · 126d
Cleared Sep 28, 2016
Sound Options Tinnitus Treatment
K161562 · KLW
Sound Options Tinnitus Treatments, Inc.
Ear, Nose, Throat · 114d
Cleared Sep 28, 2016
Acuson Freestyle Ultrasound System
K162417 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 29d
Cleared Sep 27, 2016
TRACOE smart Cuff Manager
K152865 · BSK
Tracoe Medical GmbH
Anesthesiology · 363d
Cleared Sep 27, 2016
Invacare Platinum Mobile Oxygen Concentrator
K160630 · CAW
Invacare Corporation
Anesthesiology · 204d
Cleared Sep 27, 2016
STERRAD® NX Sterilizer with ALLClear™ Technology
K160818 · MLR
Advanced Sterilization Products
General Hospital · 187d
Cleared Sep 27, 2016
MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology
K160825 · EKX
Dentsply Sirona
Dental · 186d
Cleared Sep 27, 2016
CDB Self Ligating Bracket 8F
K160957 · NJM
Cdb Corporation
Dental · 175d
Cleared Sep 27, 2016
Biopor Porous Polyethylene Implants
K161446 · GWO
Ceremed , Inc.
Neurology · 125d
Cleared Sep 27, 2016
Solana Influenza A+B Assay
K161814 · OCC
Quidel Corporation
Microbiology · 88d
Cleared Sep 27, 2016
Interlocked Circular Small Field Collimators, Elekta Integrated
K161984 · IYE
Aktina Medical Corporation
Radiology · 70d
Cleared Sep 27, 2016
TPH Spectra+ Universal Composite Restorative
K162107 · EBF
Dentsply Sirona
Dental · 60d
Cleared Sep 27, 2016
OrthoPediatrics Locking Proximal Femur System Cortical Screws
K162307 · HRS
OrthoPediatrics Corp.
Orthopedic · 41d
Cleared Sep 26, 2016
DePuy Synthes TFNA Augmentation System
K160167 · HSB
Synthes USA Products, LLC
Orthopedic · 243d
Cleared Sep 26, 2016
STERRAD 100NX Sterilizer with ALLClearTM Technology
K160903 · MLR
Advanced Sterilization Products
General Hospital · 178d
Cleared Sep 26, 2016
Endophys Blood Pressure Monitor
K160945 · DSK
Endophys Holdings, LLC
Cardiovascular · 174d
Cleared Sep 26, 2016
LUCERNA Dental Laser
K161185 · GEX
Viax Dental Lab
General & Plastic Surgery · 152d
Cleared Sep 26, 2016
Penumbra Aspiration System
K161506 · QEW
Penumbra, Inc.
Cardiovascular · 117d
Cleared Sep 26, 2016
PK AIM
K161825 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 87d