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
8137–8160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 2023
SimpleSense-BP, SimpleSense-BP Software Application
K232053 · DXN
Nanowear, Inc.
Cardiovascular · 150d
Cleared Dec 08, 2023
Novii+ Wireless Patch System
K231964 · HGM
Datex-Ohmeda
Obstetrics & Gynecology · 158d
Cleared Dec 08, 2023
DTX Studio Clinic (4.0)
K231898 · LLZ
Nobel Biocare AB
Radiology · 163d
Cleared Dec 08, 2023
F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and...
K231743 · MAX
Corelink, LLC
Orthopedic · 177d
Cleared Dec 08, 2023
NeuroBlate System
K231061 · GEX
Monteris Medical,
Neurology · 239d
Cleared Dec 08, 2023
Eagle device
K230722 · HQF
Belkin Vision, Ltd.
Ophthalmic · 267d
Cleared Dec 08, 2023
Bonelogic
K223757 · QIH
Disior, Ltd.
Radiology · 358d
Cleared Dec 08, 2023
Lumina-PTFE Titanium
K221851 · NPK
Criteria Industria E Comercio DE...
Dental · 529d
Cleared Dec 07, 2023
OTS 25 (100-1)
K233429 · MBI
Ots Medical , Ltd.
Orthopedic · 57d
Cleared Dec 07, 2023
Light Based Hair Removal Device
K232846 · OHT
Shenzhen Meik Beauty Industry Co., Ltd.
General & Plastic Surgery · 84d
Cleared Dec 07, 2023
Led Mask Platinum Exclusive MD
K232795 · OHS
Stg24 Co., Ltd.
General & Plastic Surgery · 86d
Cleared Dec 07, 2023
ProNephro AKI™ (NGAL)
K232761 · PIG
Bioporto Diagnostic, Inc.
Chemistry · 90d
Cleared Dec 07, 2023
Myocardial Strain Software Application
K232661 · LLZ
Circle Cardiovascular Imaging
Radiology · 98d
Cleared Dec 07, 2023
LOGIQ Totus
K232381 · IYN
GE Medical Systems Ultrasound and...
Radiology · 121d
Cleared Dec 07, 2023
RM Electrode (RMH 23-01)
K232273 · HLZ
Retmap, Inc.
Ophthalmic · 129d
Cleared Dec 07, 2023
ARi ExCon Implant System
K231967 · DZE
Megagen Implant Co., Ltd.
Dental · 157d
Cleared Dec 07, 2023
MySpine Cervical Guides
K231515 · QSD
Medacta International S.A.
Orthopedic · 196d
Cleared Dec 07, 2023
DLP Silicone Coronary Artery Ostial Cannulae
K231206 · DWF
Medtronic, Inc.
Cardiovascular · 224d
Cleared Dec 07, 2023
S.I.N. Dental Implant System
K231127 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 231d
Cleared Dec 07, 2023
Reliance® Fusion Sterilization Wraps
K230137 · FRG
Ahlstrom-Munksjo Nonwovens, LLC
General Hospital · 323d
Cleared Dec 06, 2023
Sonosite LX Ultrasound System
K233597 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 28d
Cleared Dec 06, 2023
LINQ II Insertable Cardiac Monitor
K233562 · MXD
Medtronic, Inc.
Cardiovascular · 30d
Cleared Dec 06, 2023
QT ECG (QTERD100)
K233521 · DXH
QT Medical, Inc.
Cardiovascular · 35d
Cleared Dec 06, 2023
Aquilion Serve SP (TSX-307B/1) V1.3
K233334 · JAK
Canon Medical Systems Corporation
Radiology · 68d