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
5113–5136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 2024
8MP Color LCD Displays C811W, C811WT, PA27 and PA27T
K233119 · PZZ
Shenzhen Beacon Display Technology...
Pathology · 458d
Cleared Dec 27, 2024
TiLink-P SI Joint Fusion System
K243835 · OUR
SurGenTec, LLC
Orthopedic · 14d
Cleared Dec 27, 2024
BioTraceIO Precision (2.0)
K243084 · QZL
Techsomed Medical Technologies , Ltd.
Radiology · 88d
Cleared Dec 27, 2024
FLASH EVD System (10-0002)
K242480 · HAW
7D Surgical ULC
Neurology · 128d
Cleared Dec 27, 2024
Power Wheelchair
K242252 · ITI
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 149d
Cleared Dec 27, 2024
BLUEDIAMOND IMPLANT
K241972 · DZE
Megagen Implant Co., Ltd.
Dental · 175d
Cleared Dec 27, 2024
Elastic Impression Material
K241924 · ELW
Beijing Okvd Biological Technology ,...
Dental · 179d
Cleared Dec 27, 2024
INNO SLA Mini Plus® Implant System
K241127 · DZE
Cowellmedi Co., Ltd.
Dental · 248d
Cleared Dec 27, 2024
OEC One ASD
K240828 · OXO
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 276d
Cleared Dec 26, 2024
iovera° System
K243677 · GXH
Pacira Biosciences, Inc.
Neurology · 29d
Cleared Dec 26, 2024
TMC Compression Implant System
K243658 · JDR
Treace Medical Concepts
Orthopedic · 29d
Cleared Dec 26, 2024
Diode Laser System (LaserPro D 980)
K243141 · GEX
Jiangxi Medex Technology Co., Ltd.
General & Plastic Surgery · 87d
Cleared Dec 26, 2024
RM STAR EX with RMS Needle
K243097 · GEI
Bomtech Electronics Co., Ltd.
General & Plastic Surgery · 87d
Cleared Dec 26, 2024
Diode Laser System model Dawn-S
K243037 · GEX
Shanghai Wonderful Opto-Electrics...
General & Plastic Surgery · 90d
Cleared Dec 26, 2024
ProSeal™ Vented Universal Vial Adaptor
K240517 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 307d
Cleared Dec 26, 2024
Straumann CARES Visual and Nova Dental CAD
K233252 · PNP
Institut Straumann AG
Dental · 455d
Cleared Dec 26, 2024
FISIOWARM 7.0
K232966 · PBX
Golden Star Srl
General & Plastic Surgery · 462d
Cleared Dec 24, 2024
SpineAR SNAP (SyncAR Spine)
K243623 · SBF
Surgical Theater, Inc.
Orthopedic · 29d
Cleared Dec 24, 2024
Insulin Syringes
K242434 · FMF
Chirana T. Injecta
General Hospital · 130d
Cleared Dec 23, 2024
NEO Pedicle Screw System™
K243693 · NKB
Neo Medical SA
Orthopedic · 24d
Cleared Dec 23, 2024
INHANCE INTACT™
K243248 · PKC
Depuy Ireland UC
Orthopedic · 73d
Cleared Dec 23, 2024
SACS PRO
K243177 · IRP
Elastimed , Ltd.
Physical Medicine · 84d
Cleared Dec 23, 2024
Denture Base
K243103 · EBI
Riton 3D Technology Co., Ltd.
Dental · 84d
Cleared Dec 23, 2024
Adora DRFi (04550010)
K242948 · JAA
Nrt X-Ray A/S
Radiology · 89d