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
2737–2760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 2025
ELID (Endoscopic Less Invasive Decompression) System
K243774 · HRX
Lesspine Innovations
Orthopedic · 264d
Cleared Aug 27, 2025
Vital Signs
K243687 · QME
Oxehealth Limited
Cardiovascular · 271d
Cleared Aug 27, 2025
Dermalage
K243166 · FRO
Infection Elimination Solutions, LLC
General & Plastic Surgery · 331d
Cleared Aug 27, 2025
Fetal & Maternal Monitor (F15A, F15A Air)
K241882 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 425d
Cleared Aug 27, 2025
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
K241766 · MWI
Fysicon BV
Cardiovascular · 433d
Cleared Aug 26, 2025
Rapid DeltaFuse
K252526 · LLZ
Ischemaview, Inc.
Radiology · 15d
Cleared Aug 26, 2025
Brainomix 360 Triage Stroke
K251983 · QAS
Brainomix Limited
Radiology · 60d
Cleared Aug 26, 2025
Ultra-Fast Vitri
K251305 · MQL
Kitazato Corporation
Obstetrics & Gynecology · 120d
Cleared Aug 26, 2025
Heager Medical Laser Family (Sabrina/Adolf)
K250261 · GEX
Heager GmbH
General & Plastic Surgery · 209d
Cleared Aug 26, 2025
Medical Video Endoscope [Standard Deflection] (URS3005)
K250049 · FGB
Seplou (Zhuhai) Co., Ltd.
Gastroenterology & Urology · 228d
Cleared Aug 26, 2025
X-Wire Guidewire
K244061 · MOF
Imperative Care, Inc.
Neurology · 238d
Cleared Aug 25, 2025
Motor and Apex Module (MaAM)
K251811 · EBW
Dentsply Sirona, Inc.
Dental · 74d
Cleared Aug 25, 2025
DenMat Multilayered Zirconia Disc
K251593 · EIH
Denmat Holding, LLC
Dental · 90d
Cleared Aug 25, 2025
CRYOcheck Chromogenic Factor VIII
K251440 · GGP
Precision Biologic, Inc.
Hematology · 108d
Cleared Aug 25, 2025
Quantra QStat Cartridge
K251404 · QFR
Hemosonics, LLC
Hematology · 111d
Cleared Aug 25, 2025
Sparrow Ascent
K251246 · PZR
Spark Biomedical, Inc.
Neurology · 125d
Cleared Aug 25, 2025
NobelZygoma TiUltra Implant system
K243834 · DZE
Nobel Biocare AB
Dental · 255d
Cleared Aug 25, 2025
PRO Pen Microneedling System (6883)
K243800 · QAI
Dermalogica, LLC
General & Plastic Surgery · 257d
Cleared Aug 25, 2025
NeuroEars-Anna™
K243709 · GWN
Neuroears, Inc.
Ear, Nose, Throat · 266d
Cleared Aug 25, 2025
Neurovascular Insight V1.0
K243680 · LLZ
Olea Medical S.A.S.
Radiology · 269d
Cleared Aug 25, 2025
Maxx Libertas Bipolar Hip Head (Bipolar Hip)
K243634 · KWY
Maxx Orthopedics, Inc.
Orthopedic · 273d
Cleared Aug 22, 2025
GBrain MRI
K252362 · QIH
Galileo Cds, Inc.
Radiology · 24d
Cleared Aug 22, 2025
Stem Extension Line (USTAR II System)
K252303 · KRO
United Orthopedic Corporation
Orthopedic · 29d
Cleared Aug 22, 2025
CARTO™ 3 EP Navigation System V8.1
K252302 · DQK
Biosense Webster, Inc.
Cardiovascular · 29d