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
6217–6240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 2024
Resolv Endoscopic Hemostat System
K234131 · QAU
Hemostasis, LLC
General & Plastic Surgery · 211d
Cleared Jul 26, 2024
VOLT™ Proximal Humerus 3.5 Plating System
K233994 · HRS
Synthes GmbH
Orthopedic · 221d
Cleared Jul 26, 2024
Spine Navigation System
K233725 · OLO
Medivis, Inc.
Orthopedic · 248d
Cleared Jul 26, 2024
EXSYS DEXi (EXSYS DEXi-D401S-FRM)
K233530 · KPR
DRTECH Corporation
Radiology · 267d
Cleared Jul 26, 2024
“LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System...
K233501 · MNR
Largan Medical Co., Ltd.
Anesthesiology · 269d
Cleared Jul 26, 2024
Vent Vial Adapter
K233287 · LHI
Hangzhou Qiantang Longyue...
General Hospital · 301d
Cleared Jul 26, 2024
Cell-Free DNA BCT
K231776 · QMA
Streck, Inc.
Chemistry · 406d
Cleared Jul 26, 2024
EasyStat 300
K220328 · CGA
Medica Corporation
Chemistry · 903d
Cleared Jul 25, 2024
GI Genius™ Module 100 (GGM100.US)
K241887 · QNP
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 27d
Cleared Jul 25, 2024
Grappler Interference Screw System
K241864 · MBI
Paragon 28, Inc.
Orthopedic · 28d
Cleared Jul 25, 2024
Arthrex Synergy Vision Endoscopic Imaging System
K241361 · GCJ
Arthrex, Inc.
General & Plastic Surgery · 72d
Cleared Jul 25, 2024
PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA,...
K241203 · OHS
Dongguan Hunter Electronic Technology...
General & Plastic Surgery · 86d
Cleared Jul 25, 2024
Spine Guidance Software (Version 5.1)
K241171 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 90d
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