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: 2026–2026 ×
1,642 results
961–984 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Mar 24, 2026
NanoKnife Generator (H78720300351US0)
K253198 · OAB
Angiodynamics
Gastroenterology & Urology · 179d
Cleared Mar 24, 2026
PRESSONE™
K253047 · FMI
Nipro Medical Corporation
General Hospital · 183d
Cleared Mar 24, 2026
JLK-NCCT
K252421 · QAS
JLK, Inc.
Radiology · 235d
Cleared Mar 24, 2026
Access BNP II
K252169 · NBC
Beckman Coulter, Inc.
Chemistry · 257d
Cleared Mar 24, 2026
Trinias
K252099 · OWB
Shimadzu Corporation
Radiology · 264d
Cleared Mar 23, 2026
LED Light Therapy Masks (LumiLips FAC07NA)
K260202 · OHS
Guangdong Newdermo Biotech Co., Ltd.
General & Plastic Surgery · 59d
Cleared Mar 23, 2026
QuikFix External Fixator: Knee-Spanning Pack
K260112 · KTT
Stabiliz Orthopaedics, Inc.
Orthopedic · 68d
Cleared Mar 23, 2026
Clavicle Fixation System
K254288 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 82d
Cleared Mar 23, 2026
HyperSuture All Green Extension Line
K254275 · GAT
Threadstone, LLC
General & Plastic Surgery · 83d
Cleared Mar 23, 2026
MDx-Chex for BCN
K254166 · PMN
Streck
Microbiology · 90d
Cleared Mar 23, 2026
True Definition DL
K253686 · JAK
Ge Healthcare Japan Corporation
Radiology · 122d
Cleared Mar 23, 2026
CT Rembra RT
K252992 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 186d
Cleared Mar 23, 2026
Adin Long Dental Implant System
K252031 · DZE
Adin Dental Implant Systems , Ltd.
Dental · 266d
Cleared Mar 20, 2026
Noxturnal Web
K260585 · OLV
Nox Medical Ehf
Neurology · 28d
Cleared Mar 20, 2026
Arthrex FiberTak Suture Anchor
K260561 · MBI
Arthrex, Inc.
Orthopedic · 29d
Cleared Mar 20, 2026
HemosIL Factor V Leiden (APC Resistance V)
K260551 · GGW
Instrumentation Laboratory (IL) Co.
Hematology · 30d
Cleared Mar 20, 2026
FMD Peripheral Guide Wire F-14 Flex 6
K260544 · DQX
FMD Co., Ltd.
Cardiovascular · 30d
Cleared Mar 20, 2026
Smart Fit TorsoCardiac 1.5T
K260519 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 31d
Cleared Mar 20, 2026
Valvuloplasty Balloon Catheter (ValvuloPro)
K260437 · OZT
Dongguan TT Medical, Inc.
Cardiovascular · 37d
Cleared Mar 20, 2026
FLOWRUNNER Aspiration System
K254208 · QEZ
Expanse Medical, Inc.
Cardiovascular · 81d
Cleared Mar 20, 2026
Percutaneous Endoscopic Gastrostomy (PEG) Kit
K254170 · PIF
Degania Silicone , Ltd.
Gastroenterology & Urology · 87d
Cleared Mar 20, 2026
NOMAD Pro 3
K253864 · EHD
Dental Imaging Technologies Corporation
Radiology · 107d
Cleared Mar 20, 2026
Electric wheelchair (JJW-7002, JJW-7003)
K253849 · ITI
ZheJiang J&J Mobility Co., Ltd.
Physical Medicine · 108d
Cleared Mar 20, 2026
TiLink-L Navigation Instruments
K253604 · OLO
SurGenTec, LLC
Orthopedic · 122d