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
1249–1272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 2026
“POINT” Kinguide Agile Hybrid Navigation System
K252989 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 155d
Cleared Feb 20, 2026
CARTO™ 3 EP Navigation System V8.4
K252972 · DQK
Biosense Webster, Inc.
Cardiovascular · 156d
Cleared Feb 20, 2026
CaseBio™ Culture w/HSA (CMH5)
K252672 · MQL
Casebioscience, Inc.
Obstetrics & Gynecology · 179d
Cleared Feb 20, 2026
QSCHECK UISACR
K252619 · JFY
Qstag, Inc.
Chemistry · 185d
Cleared Feb 20, 2026
CARA System
K252500 · OWB
Cara Medical, Ltd.
Radiology · 196d
Cleared Feb 20, 2026
Disposable Ureteral Stents
K251890 · FAD
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 245d
Cleared Feb 20, 2026
SPRY TMS Therapy System (0550)
K251653 · OBP
Soterix Medical, Inc.
Neurology · 267d
Cleared Feb 19, 2026
TrueFit Bolus
K260308 · MUJ
Adaptiiv Medical Technologies, Inc.
Radiology · 20d
Cleared Feb 19, 2026
LacertaMatrix
K260218 · KGN
Lacerta Life Sciences
General & Plastic Surgery · 27d
Cleared Feb 19, 2026
AS Software Version Asera
K260205 · LLZ
AS Software, LLC
Radiology · 27d
Cleared Feb 19, 2026
AuST CSP Introducer
K260163 · DYB
CenterPoint Systems, LLC
Cardiovascular · 30d
Cleared Feb 19, 2026
Meniscus Versaflex
K254188 · GAT
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 58d
Cleared Feb 19, 2026
VERTICALE GPS Instruments
K254148 · OLO
Silony Medical GmbH
Orthopedic · 59d
Cleared Feb 19, 2026
Portable Dental X-ray Device (GT-1)
K254018 · EHD
Guilin Refine Medical Instrument Co.,...
Radiology · 66d
Cleared Feb 19, 2026
Access anti-HBc Total
K253687 · SEI
Beckman Coulter, Inc.
Microbiology · 90d
Cleared Feb 19, 2026
Spine Guidance 5.4 Software
K253623 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 93d
Cleared Feb 19, 2026
Acclarent AERA Eustachian Tube Balloon Dilation System
K253612 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 93d
Cleared Feb 19, 2026
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
K253398 · FXX
Efofex, Inc.
General Hospital · 142d
Cleared Feb 19, 2026
Retrograde Coronary Sinus Perfusion Cannulae
K253203 · DWF
Medtronic, Inc.
Cardiovascular · 146d
Cleared Feb 19, 2026
SkinStylus SteriLock MicroSystem (MP1209SL)
K253002 · QAI
Esthetic Medical, Inc.
General & Plastic Surgery · 153d
Cleared Feb 19, 2026
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe
K252814 · QNQ
CMT Health PTE., Ltd.
General Hospital · 168d
Cleared Feb 19, 2026
ATLAS™ Expandable Osteotomy Wedge System
K252733 · PLF
MiRus, LLC
Orthopedic · 175d
Cleared Feb 19, 2026
Valence Robotic Navigation System
K252597 · OLO
Alphatec Spine, Inc.
Orthopedic · 188d
Cleared Feb 19, 2026
Monaco RTP System (6.3)
K252002 · MUJ
Elekta Solutions AB
Radiology · 237d