FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
6505–6528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2024
Atellica® IM High-Sensitivity Troponin I (TnIH)
K241165 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 90d
Cleared Jul 25, 2024
s-Clean ScanHealing Abutment
K241063 · NHA
Dentis Co., Ltd.
Dental · 98d
Cleared Jul 25, 2024
Fluent Pro Fluid Management System (FLT-200)
K240886 · HIG
Hologic, Inc.
Obstetrics & Gynecology · 115d
Cleared Jul 25, 2024
Navident
K233563 · PLV
Claronav, Inc.
Dental · 262d
Cleared Jul 25, 2024
KARL STORZ Fiber Telescopes for Urology
K233372 · FGB
Karl Storz SE & CO. KG
Gastroenterology & Urology · 297d
Cleared Jul 24, 2024
Erisma® Lp Spinal Fixation System
K241863 · NKB
Clariance
Orthopedic · 27d
Cleared Jul 24, 2024
Non-Sterile Ultrasound Transmission Gels
K241789 · MUI
Hony Medical Co., Ltd.
Radiology · 33d
Cleared Jul 24, 2024
P-SCOPE
K241502 · GCJ
Oui Medical, Inc.
General & Plastic Surgery · 57d
Cleared Jul 24, 2024
Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)
K241243 · DQK
Centerline Biomedical, Inc.
Cardiovascular · 82d
Cleared Jul 24, 2024
MISTI Silicone Implant
K241150 · MIB
Keosan Trading Co.
General & Plastic Surgery · 90d
Cleared Jul 24, 2024
“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)
K241130 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 91d
Cleared Jul 24, 2024
InMode RF System
K240780 · GEI
Inmode , Ltd.
General & Plastic Surgery · 125d
Cleared Jul 24, 2024
Insure® Universal
K240714 · EMA
Cosmedent, Inc.
Dental · 131d
Cleared Jul 24, 2024
C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
K240457 · GEH
Pentax of America, Inc.
General & Plastic Surgery · 159d
Cleared Jul 24, 2024
ExacTrac Dynamic (2.0)
K240431 · IYE
Brainlab AG
Radiology · 161d
Cleared Jul 24, 2024
CADDIE
K240044 · QNP
Odin Medical Limited
Gastroenterology & Urology · 201d
Cleared Jul 24, 2024
X-Smart Pro
K233865 · EKX
Dentsply Sirona, Inc.
Dental · 231d
Cleared Jul 24, 2024
Aptima HCV Quant Dx Assay
K233352 · MZP
Hologic, Inc.
Microbiology · 299d
Cleared Jul 24, 2024
FlexWing Anterior Cervical Plate System
K231251 · KWQ
Jeil Medical Corporation
Orthopedic · 450d
Cleared Jul 24, 2024
THE Graft Collagen
K230305 · NPM
Purgo Biologics, Inc.
Dental · 537d
Cleared Jul 23, 2024
Gaudi Proximal Humerus Plate
K241296 · HRS
Netbiologics, LLC
Orthopedic · 76d
Cleared Jul 23, 2024
EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)
K241114 · LLZ
Ewoosoft Co., Ltd.
Radiology · 92d
Cleared Jul 23, 2024
TE Air Diagnostic Ultrasound System
K240906 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 112d
Cleared Jul 23, 2024
AITRICS-VC
K240756 · PLB
Aitrics Co., Ltd.
Cardiovascular · 125d