FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
817–840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 2026
BlueDop Vascular Expert
K260700 · DPW
BlueDop Medical, Ltd.
Cardiovascular · 126d
Cleared Jul 08, 2026
ThermAffyx(TM) Patient Safety System
K260278 · DWJ
Stihler Electronic GmbH
Cardiovascular · 160d
Cleared Jul 08, 2026
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
K260160 · SAN
bioMerieux, Inc.
Microbiology · 169d
Cleared Jul 08, 2026
C.A. Medical Interbody Fusion System
K254130 · ODP
C.A. Medical, LLC
Orthopedic · 198d
Cleared Jul 08, 2026
CXRDetectAI
K253751 · QFM
Neurocareai, Inc. (Dba Savelife.Ai)
Radiology · 225d
Cleared Jul 07, 2026
Luja Soft
K262045 · EZD
Coloplast A/S
Gastroenterology & Urology · 20d
Cleared Jul 07, 2026
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens
K261812 · MVN
Hoya Lamphun , Ltd.
Ophthalmic · 36d
Cleared Jul 07, 2026
Electric wheelchair (XW-LY007 )
K261164 · ITI
Yongkang Ruihe Metal Product Co., Ltd.
Physical Medicine · 89d
Cleared Jul 07, 2026
Mobility Scooter (R200)
K261163 · INI
Yongkang Ruihe Metal Product Co., Ltd.
Physical Medicine · 89d
Cleared Jul 07, 2026
InferOperate Suite
K260973 · QIH
Beijing Infervision Healthcare...
Radiology · 105d
Cleared Jul 07, 2026
Pulmonex II Xenon System (132-503)
K253942 · IYT
Mirion Technologies (Capintec), Inc.
Radiology · 210d
Cleared Jul 06, 2026
Plum Vagiceuticals™ Vaginal Moisturizing Suppositories
K261909 · NUC
Pcca, Inc.
Obstetrics & Gynecology · 28d
Cleared Jul 06, 2026
Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/...
K261529 · DYB
Hartman Medical Group, LLC
Cardiovascular · 59d
Cleared Jul 06, 2026
INDIRA CLOUD VIEWER
K261465 · LLZ
INDIGO TECHNOLOGIES
Radiology · 63d
Cleared Jul 06, 2026
MobileLink Acetabular Cup System – 40mm ID Inserts (various)
K261009 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 102d
Cleared Jul 06, 2026
Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)
K260122 · QRL
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 172d
Cleared Jul 06, 2026
Cytrans™ Elashield
K253317 · LYC
GC America, Inc.
Dental · 279d
Cleared Jul 02, 2026
HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology
K261897 · FRG
O&M Halyard, Inc.
General Hospital · 27d
Cleared Jul 02, 2026
FUJIFILM Processor EP-8000
K261880 · FET
Fujifilm Corporation
Gastroenterology & Urology · 27d
Cleared Jul 02, 2026
Xpert Carba-R
K261867 · POC
Cepheid
Microbiology · 28d
Cleared Jul 02, 2026
iTero Lumina™ Pro
K261847 · NTK
Align Technology , Ltd.
Dental · 29d
Cleared Jul 02, 2026
Amplatzer TorqVue LP Delivery System
K261825 · DQY
Abbott
Cardiovascular · 30d
Cleared Jul 02, 2026
Insufflation Retention Device (IRD) (11173-325-101)
K261587 · FDF
Bpendo, LLC
Gastroenterology & Urology · 50d
Cleared Jul 02, 2026
OrthoFit
K261129 · DYH
Spident Co., Ltd.
Dental · 87d