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
937–960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 2026
Arterial Pressure Monitoring Set/Tray
K254278 · DQO
Spectrum Vascular
Cardiovascular · 85d
Cleared Mar 25, 2026
LYNX COBLATION Laryngeal Wand (72290254)
K253680 · GEI
ArthroCare Corporation
General & Plastic Surgery · 124d
Cleared Mar 25, 2026
Invictus Bands System
K253615 · OWI
Alphatec Spine, Inc.
Orthopedic · 127d
Cleared Mar 25, 2026
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
K253406 · LHN
Mevion Medical Systems, Inc.
Radiology · 176d
Cleared Mar 25, 2026
Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with...
K253322 · BZE
Medline Industries, LP
Anesthesiology · 176d
Cleared Mar 25, 2026
Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A...
K253184 · EOB
Zhuhai Wesee Meditech Co., Ltd.
Ear, Nose, Throat · 180d
Cleared Mar 25, 2026
Easydrip Classic Pen Needle
K252908 · FMI
Sandstone Medical (Suzhou), Inc.
General Hospital · 194d
Cleared Mar 25, 2026
Flex-Z™ Cervical Cage
K252432 · ODP
Spinepoint, LLC
Orthopedic · 236d
Cleared Mar 25, 2026
Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455,...
K252052 · HQC
Bausch and Lomb, Incorporated
Ophthalmic · 267d
Cleared Mar 25, 2026
CUVIS-joint (CJ150)
K252037 · OLO
Curexo, Inc.
Orthopedic · 268d
Cleared Mar 25, 2026
MiraChlor Antimicrobial Wound Solution
K252023 · FRO
Letus Corporation
General & Plastic Surgery · 268d
Cleared Mar 24, 2026
FebriDx Bacterial/Non-bacterial Assay
K260787 · QXA
Lumos Diagnostics, Inc.
Microbiology · 14d
Cleared Mar 24, 2026
LOGIQ Vita
K260673 · IYN
GE Medical Systems Ultrasound and...
Radiology · 22d
Cleared Mar 24, 2026
Senographe Pristina
K260087 · MUE
GE Medical Systems SCS
Radiology · 71d
Cleared Mar 24, 2026
LOQTEQ® VA Proximal Humerus Plate 3.5
K254253 · HRS
Aap Implantate AG
Orthopedic · 85d
Cleared Mar 24, 2026
Electric Wheelchair (E201)
K254012 · ITI
Nanjing CareMoving Rehabilitation...
Physical Medicine · 99d
Cleared Mar 24, 2026
NanoKnife Generator (H78720300351US0)
K253198 · OAB
Angiodynamics
Gastroenterology & Urology · 179d
Cleared Mar 24, 2026
PRESSONE™
K253047 · FMI
Nipro Medical Corporation
General Hospital · 183d
Cleared Mar 24, 2026
JLK-NCCT
K252421 · QAS
JLK, Inc.
Radiology · 235d
Cleared Mar 24, 2026
Access BNP II
K252169 · NBC
Beckman Coulter, Inc.
Chemistry · 257d
Cleared Mar 24, 2026
Trinias
K252099 · OWB
Shimadzu Corporation
Radiology · 264d
Cleared Mar 23, 2026
LED Light Therapy Masks (LumiLips FAC07NA)
K260202 · OHS
Guangdong Newdermo Biotech Co., Ltd.
General & Plastic Surgery · 59d
Cleared Mar 23, 2026
QuikFix External Fixator: Knee-Spanning Pack
K260112 · KTT
Stabiliz Orthopaedics, Inc.
Orthopedic · 68d
Cleared Mar 23, 2026
Clavicle Fixation System
K254288 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 82d