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
1729–1752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2025
CE Deliver (DLV)
K252480 · NEZ
CapsoVision, Inc.
Gastroenterology & Urology · 134d
Cleared Dec 19, 2025
Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)
K252342 · HGX
Guangdong Youmeng Electrical...
Obstetrics & Gynecology · 144d
Cleared Dec 19, 2025
eMurmur Heart AI
K252284 · DQD
Csd Labs
Cardiovascular · 150d
Cleared Dec 19, 2025
Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling...
K252167 · FRO
Qingdao Bright Moon Biomedical...
General & Plastic Surgery · 162d
Cleared Dec 19, 2025
AI-CVD
K252029 · QIH
HeartLung Corporation
Radiology · 172d
Cleared Dec 19, 2025
Spo2 Sensor CSS032D
K251751 · DQA
Shenzhen Ykd Technology Co., Ltd.
Anesthesiology · 193d
Cleared Dec 19, 2025
LIA Console (542-7)
K251730 · NQQ
Leadoptik, Inc.
General & Plastic Surgery · 196d
Cleared Dec 19, 2025
eRapid with eTrack System
K251572 · CAF
Pari Respiratory Equipment, Inc.
Anesthesiology · 211d
Cleared Dec 19, 2025
Endura™ Ureteral Stent and Stent Set
K251469 · FAD
Cathegenix (Xiamen) Co., Ltd.
Gastroenterology & Urology · 220d
Cleared Dec 19, 2025
LIA-1 Catheter (542-1)
K251402 · KTI
Leadoptik, Inc.
Anesthesiology · 227d
Cleared Dec 19, 2025
DBLG2
K251152 · QJI
Diabeloop
Chemistry · 249d
Cleared Dec 19, 2025
Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)
K251143 · DXN
Ningbo Ranor Medical Science &...
Cardiovascular · 249d
Cleared Dec 19, 2025
JOULE 1064nm System and Accessories
K251077 · GEX
Sciton, Inc
General & Plastic Surgery · 255d
Cleared Dec 19, 2025
Tru Liver Health Test Panel
K251074 · CJE
Truvian Health
Chemistry · 255d
Cleared Dec 19, 2025
Pectus Versa System
K251050 · HRS
Gm Dos Reis Industria E Comercio
Orthopedic · 260d
Cleared Dec 19, 2025
Rectal Applicator
K251037 · JAQ
Nucletron B.V.
Radiology · 260d
Cleared Dec 19, 2025
Chiavaye Personal Moisturizer
K251011 · NUC
Unipack, LLC
Obstetrics & Gynecology · 262d
Cleared Dec 19, 2025
CO2 Laser Therapy System (Model: LFS-D9U)
K250998 · GEX
Sanhe?Lefis?Electronics?Co., Ltd.
General & Plastic Surgery · 262d
Cleared Dec 19, 2025
Airbile-100
K250976 · IZL
Poskom Co., Ltd.
Radiology · 263d
Cleared Dec 19, 2025
MatriDerm pluS+ Bi-Layer
K250864 · KGN
Medskin Solutions Dr. Suwelack AG
General & Plastic Surgery · 273d
Cleared Dec 19, 2025
Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
K250314 · PNE
Surgical Instrument Service and...
Cardiovascular · 318d
Cleared Dec 19, 2025
Vivo 45 LS
K232365 · CBK
Oconnell Regulatory Consultants, Inc.
Anesthesiology · 865d
Cleared Dec 18, 2025
MOVIVA® Hybrid Ablation Probe
K253915 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 10d
Cleared Dec 18, 2025
Dental Cone
K253758 · OLR
Medizin Produkte Neustadt GmbH (Mpn)
Dental · 23d