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: Cleared only ×
175,230 results
3937–3960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2025
Mobius3D (4.1)
K250099 · IYE
Varian Medical Systems
Radiology · 122d
Cleared May 16, 2025
OTS Hip
K250086 · OLO
Ortoma AB
Orthopedic · 123d
Cleared May 16, 2025
Electric Nasal Aspirator...
K244033 · BTA
Shenzhen Desida Technology Co., Ltd.
Ear, Nose, Throat · 137d
Cleared May 16, 2025
Spectral CT
K244008 · JAK
Philips Medical Systems Technologies...
Radiology · 141d
Cleared May 16, 2025
MobileLink Acetabular Cup System - inhouse coatings
K243927 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 147d
Cleared May 16, 2025
iBSM
K243837 · DRG
Iorbit Digital Technologies Private...
Cardiovascular · 154d
Cleared May 16, 2025
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
K243617 · JAK
Shanghai United Imaging Healthcare...
Radiology · 175d
Cleared May 16, 2025
Arthrex Spine Endoscope
K243602 · HRX
Arthrex, Inc.
Orthopedic · 176d
Cleared May 16, 2025
Byonyks X-1 APD Cycler
K243371 · FKX
Byonyks Pvt, Ltd.
Gastroenterology & Urology · 198d
Cleared May 16, 2025
BLESSING System
K243176 · GEI
Cellah Medical Co., Ltd.
General & Plastic Surgery · 228d
Cleared May 16, 2025
Ruby Intravascular Catheter
K243105 · FOZ
Venocare, Inc.
General Hospital · 228d
Cleared May 16, 2025
MasteRad MiniX Mobile Digital Imaging System (Mini-X)
K242731 · OWB
Medicatech USA, Inc.
Radiology · 248d
Cleared May 16, 2025
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
K242706 · SET
Fujirebio Diagnostics,Inc.
Immunology · 249d
Cleared May 16, 2025
Cystatin C
K242585 · NDY
SENTINEL CH. SpA
Chemistry · 259d
Cleared May 16, 2025
Mixed Reality Spine Navigation
K242569 · SBF
Brainlab AG
Orthopedic · 261d
Cleared May 16, 2025
Clearo
K242438 · NHJ
Breas Medical AB
Anesthesiology · 273d
Cleared May 16, 2025
6450 Ultrasound System (MyLabE80)
K241671 · IYN
Esaote, S.P.A.
Radiology · 339d
Cleared May 16, 2025
Hemodialysis Catheter
K241581 · MSD
Haolang Medical USA Corporation
Gastroenterology & Urology · 347d
Cleared May 16, 2025
InferRead Lung CT.AI
K240554 · OEB
Infervision Medical Technology Co., Ltd.
Radiology · 443d
Cleared May 15, 2025
Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
K251186 · LDF
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared May 15, 2025
NPseal
K251156 · OKO
Guard Medical, Inc.
General & Plastic Surgery · 30d
Cleared May 15, 2025
HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
K250454 · JTN
Hardy Diagnostics
Microbiology · 86d
Cleared May 15, 2025
NeurAxis IB-Stim (01-1020)
K250451 · QHH
Neuraxis
Gastroenterology & Urology · 86d
Cleared May 15, 2025
NEXUS® Hip Stem
K250444 · LZO
Microport Orthopedics, Inc.
Orthopedic · 90d