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
6481–6504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 2024
Introcan Safety® 2 IV Catheter
K241845 · FOZ
B.Braun Medical, Inc.
General Hospital · 30d
Cleared Jul 26, 2024
Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
K241800 · MRR
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 26, 2024
NEXA™ NPWT System
K241515 · OMP
Nexa Medical Limited
General & Plastic Surgery · 58d
Cleared Jul 26, 2024
Pantheon Pedicle Screw and Iliac Bolt Fixation System
K241494 · NKB
Pantheon Spinal
Orthopedic · 59d
Cleared Jul 26, 2024
Alien Aligners
K241187 · NXC
Alien Milling Technologies
Dental · 88d
Cleared Jul 26, 2024
Tandem Mobi Insulin Pump with interoperable technology
K241078 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 98d
Cleared Jul 26, 2024
Luja female (20051)
K241028 · EZD
Coloplast
Gastroenterology & Urology · 102d
Cleared Jul 26, 2024
STAR Apollo™ Mapping System
K240509 · DQK
Rhythm AI, Ltd.
Cardiovascular · 155d
Cleared Jul 26, 2024
ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001,...
K240401 · HIH
Origyn Medical Technology (Hangzhou)...
Obstetrics & Gynecology · 168d
Cleared Jul 26, 2024
Accusafe Transseptal Guidewire (GTR31180, GTR31230)
K240246 · DRC
Synaptic Medical Corporation
Cardiovascular · 178d
Cleared Jul 26, 2024
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
K240169 · HQC
Bausch and Lomb, Incorporated
Ophthalmic · 186d
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