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
7945–7968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2023
Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
K232717 · LQY
Changzhou Haili Medical Co., Ltd.
Dental · 108d
Cleared Dec 22, 2023
MAGNETOM Sola
K232535 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 123d
Cleared Dec 22, 2023
ART-Plan
K232479 · MUJ
Therapanacea
Radiology · 128d
Cleared Dec 22, 2023
Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344,...
K232338 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 140d
Cleared Dec 22, 2023
ElastiMed SACS
K232300 · JOW
Elastimed , Ltd.
Cardiovascular · 143d
Cleared Dec 22, 2023
kallisio stentra™ oral stent
K232293 · IYE
Kallisio, Inc.
Radiology · 143d
Cleared Dec 22, 2023
qXR-LN
K231805 · MYN
Qure.Ai Technologies
Radiology · 185d
Cleared Dec 22, 2023
Elegant™ Advanced CompHort
K231794 · NUC
Viramal Limited
Obstetrics & Gynecology · 185d
Cleared Dec 22, 2023
CPM System
K231086 · MWI
Analog Devices, Inc.
Cardiovascular · 249d
Cleared Dec 22, 2023
WellCare Anoscope
K230439 · FER
Well Care (Wuhan) Medical Technology...
Gastroenterology & Urology · 304d
Cleared Dec 22, 2023
NeuMoDx CT/NG Assay 2.0
K230267 · QEP
Neumodx Molecular, Inc.
Microbiology · 325d
Cleared Dec 22, 2023
Novae® Dual Mobility System, Hype® Hip System
K223745 · LZO
Serf
Orthopedic · 373d
Cleared Dec 21, 2023
Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
K233848 · KNF
Gynesonics, Inc.
Obstetrics & Gynecology · 16d
Cleared Dec 21, 2023
Bearing nsPVA Express™
K233813 · NAJ
Merit Medical Systems, Inc.
Obstetrics & Gynecology · 21d
Cleared Dec 21, 2023
Hoffmann LRF System
K233741 · KTT
Stryker GmbH
Orthopedic · 29d
Cleared Dec 21, 2023
Stryker Orthopaedics Hip Systems Labeling Update
K233498 · LPH
Howmedica Osteonics Corp., Dba...
Orthopedic · 51d
Cleared Dec 21, 2023
RadiForce MX317W
K233465 · PGY
Eizo Corporation
Radiology · 58d
Cleared Dec 21, 2023
Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System
K233423 · HRS
Tyber Medical, LLC
Orthopedic · 72d
Cleared Dec 21, 2023
Cannulated Screw System
K233396 · HWC
Smith & Nephew, Inc.
Orthopedic · 79d
Cleared Dec 21, 2023
Reusable Blood Pressure Cuff
K233276 · DXQ
Suzhou Minhua Medical Apparatus...
Cardiovascular · 83d
Cleared Dec 21, 2023
SkyOPS™ Orthopedic Plate System
K233154 · HRS
Sky Surgical, LLC
Orthopedic · 85d
Cleared Dec 21, 2023
HM70 EVO Diagnostic Ultrasound System
K233112 · IYN
Samsung Medison Co., Ltd.
Radiology · 85d
Cleared Dec 21, 2023
PICOSECOND Nd:YAG Laser System
K233018 · GEX
Ids, Ltd.
General & Plastic Surgery · 90d
Cleared Dec 21, 2023
Dental Glass Ceramics
K233016 · EIH
Shenzhen Yurucheng Dental Materials...
Dental · 90d