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: 2026–2026 ×
1,922 results
241–264 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Not Cleared Jul 06, 2026
TESSA Spatial Surgery System
DEN250037 · SIQ
Smith & Nephew, Inc.
Orthopedic · 318d
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
Cleared Jul 02, 2026
OptraSCAN System
K260755 · NOT
Optrascan, Inc.
Pathology · 115d
Cleared Jul 02, 2026
Collagen Wound Powder
K260596 · KGN
Ventris Medical
General & Plastic Surgery · 128d
Cleared Jul 02, 2026
OncoStudio
K260528 · QKB
Oncosoft. Inc.,
Radiology · 135d
Cleared Jul 02, 2026
FACE4D Aligner
K260527 · NXC
Avinent Implant System S.L.U.
Dental · 135d
Cleared Jul 02, 2026
Koios DS (3.8)
K253884 · POK
Koios Medical, Inc.
Radiology · 210d
Cleared Jul 02, 2026
iPredict-DR
K253704 · PIB
iHealthscreen, Inc.
Ophthalmic · 220d
Cleared Jul 02, 2026
ILR ECG Analyzer (IM007)
K253463 · DQK
Implicity, Inc.
Cardiovascular · 267d
Cleared Jul 02, 2026
SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
K252463 · DPS
Edan Instruments, Inc.
Cardiovascular · 330d
Cleared Jul 02, 2026
Fastplex™ BCR-ABL (p210) %IS digital PCR Kit
K252243 · OYX
Suzhou Precigenome, Ltd. Co;
Medical Genetics · 349d
Not Cleared Jul 02, 2026
Claria System
DEN250034 · SIM
Claria Medical, Inc.
Obstetrics & Gynecology · 329d