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: 2026–2026 ×
1,642 results
1249–1272 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Feb 23, 2026
VITA VMLC Primer
K251587 · KLE
Vita Zahnfabrik H. Rauter GmbH & Co. Kg.
Dental · 276d
Cleared Feb 22, 2026
Single Use Distal Cover MAJ-2315 (MAJ-2315)
K253646 · FDT
Olympus Medical Systems Corp.
Gastroenterology & Urology · 94d
Cleared Feb 21, 2026
Advanced Tissue Resection Device
K251692 · FDI
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 264d
Cleared Feb 20, 2026
LF Process Indicator Tape for Steam Sterilization
K260181 · JOJ
Intertape Polymer Group
General Hospital · 30d
Cleared Feb 20, 2026
KLS Martin Ixos System
K254162 · HRS
KLS-Martin L.P.
Orthopedic · 60d
Cleared Feb 20, 2026
FAQ™ (LED Panel)
K253683 · OHS
Foreo, Inc.
General & Plastic Surgery · 91d
Cleared Feb 20, 2026
KLS Martin Pure Pectus System
K253660 · HRS
KLS-Martin L.P.
Orthopedic · 92d
Cleared Feb 20, 2026
Xpert Hemorrhagic Fever
K253653
Cepheid
Microbiology · 92d
Cleared Feb 20, 2026
Safety Heel Lancet
K253605 · FMK
Ningbo Medsun Medical Co., Ltd.
General & Plastic Surgery · 94d
Cleared Feb 20, 2026
BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)
K253445 · FQH
Bd
General & Plastic Surgery · 141d
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