FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
3121–3144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 2025
Disposable Biopsy Needle
K243296 · KNW
Carbon (Shenzhen) Medical Device Co.,...
General & Plastic Surgery · 266d
Cleared Jul 11, 2025
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B...
K243274 · OZE
Centers For Disease Control and...
Microbiology · 268d
Cleared Jul 11, 2025
B-Scan
K243227 · IYO
Accutome, Inc. Doing Business AS...
Radiology · 276d
Cleared Jul 11, 2025
Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
K241179 · QYX
Vivaquant, Inc.
Cardiovascular · 438d
Cleared Jul 10, 2025
TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
K251945 · HRS
TriMed, Inc.
Orthopedic · 15d
Cleared Jul 10, 2025
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
K251885 · MRW
Providence Medical Technology, Inc.
Orthopedic · 20d
Cleared Jul 10, 2025
Sonosite LX Ultrasound System
K251830 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 27d
Cleared Jul 10, 2025
Vivid Pioneer
K251169 · IYN
GE Medical Systems Ultrasound and...
Radiology · 86d
Cleared Jul 10, 2025
Arthrex PushLock Suture Anchors
K251145 · MBI
Arthrex, Inc.
Orthopedic · 87d
Cleared Jul 10, 2025
RAP Femoral Venous Cannulae
K250283 · DWF
LivaNova USA, Inc.
Cardiovascular · 160d
Cleared Jul 10, 2025
CONDUIT™ SYNFIX™ Evolution Secured Spacer System
K250072 · OVD
Avalign Technologies, Inc.
Orthopedic · 181d
Cleared Jul 10, 2025
ARENA Star, Galaxy Star
K250063 · EIH
Arum Dentistry Co., Ltd.
Dental · 181d
Cleared Jul 10, 2025
Marquee™ Disposable Core Biopsy Instrument and Instrument Kit
K250032 · KNW
Bard Peripheral Vascular, Inc.
General & Plastic Surgery · 184d
Cleared Jul 10, 2025
Microcurrent Facial Device (CEC101, EE0101, EEI101)
K244004 · NFO
Shenzhen Dachi Communication Co., Ltd.
Neurology · 196d
Cleared Jul 10, 2025
ZBPro Diagnostic
K243252 · DPS
Zbeats, Inc.
Cardiovascular · 268d
Cleared Jul 09, 2025
Flexiva Pulse Laser Fiber
K251759 · GEX
Boston Scientific Corporation
Gastroenterology & Urology · 30d
Cleared Jul 09, 2025
Cios Alpha
K251520 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 54d
Cleared Jul 09, 2025
EZ-FIDUCIALS
K250505 · HAW
Phasor Health, LLC
Neurology · 138d
Cleared Jul 09, 2025
panaSIa SI Fusion System
K250247 · OUR
Wenzel Spine, Inc.
Orthopedic · 163d
Cleared Jul 09, 2025
Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs,...
K250193 · LZA
Basic Medical Technology, Inc.
General Hospital · 167d
Cleared Jul 09, 2025
HARBOR Occlusion Device
K250133 · KRD
Nuvascular, Inc.
Cardiovascular · 173d
Cleared Jul 09, 2025
OptiVu™ Shoulder
K250108 · SBF
Mr Surgical Solutions, LLC
Orthopedic · 174d
Cleared Jul 09, 2025
HEXIM Implant
K243731 · DZE
P&A USA
Dental · 217d
Cleared Jul 09, 2025
ARCHITECT iGentamicin
K243500 · LCD
Abbott Laboratories
Toxicology · 239d