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
2281–2304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2025
Immunoglobulin Isotypes (GAM) for the EXENT Analyser
K250159 · SGG
The Binding Site Group , Ltd.
Immunology · 269d
Cleared Oct 17, 2025
Biopsy Port Adapter
K250145 · ODC
Endosound, Inc.
Gastroenterology & Urology · 269d
Cleared Oct 16, 2025
TargetCool™ (RM-DT02W)
K253114 · GEH
Recensmedical, Inc.
General & Plastic Surgery · 22d
Cleared Oct 16, 2025
ProZip Knotless Implant
K253024 · GAT
Riverpoint Medical
General & Plastic Surgery · 27d
Cleared Oct 16, 2025
CryoFreeze Wart and Skin Tag Remover
K253000 · GEH
Cryosurgery, Inc.
General & Plastic Surgery · 28d
Cleared Oct 16, 2025
Profoject™ Disposable Needle
K252631 · FMI
CMT Health PTE., Ltd.
General Hospital · 57d
Cleared Oct 16, 2025
INDIGO® Aspiration System – Lightning Flash Aspiration Tubing
K252612 · QEW
Penumbra, Inc.
Cardiovascular · 58d
Cleared Oct 16, 2025
Viewer (5.4)
K252476 · LLZ
Brainlab AG
Radiology · 70d
Cleared Oct 16, 2025
Injector Force Max Single Use Injector (NM-400L)
K252247 · FBK
Olympus Medical Systems Corporation
Gastroenterology & Urology · 90d
Cleared Oct 16, 2025
Alpha Endo Handpiece (Alpha Endo)
K252223 · EKX
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Dental · 92d
Cleared Oct 16, 2025
FFX Facet Fixation System
K252153 · MRW
Sc Medica
Orthopedic · 99d
Cleared Oct 16, 2025
Light Therapy Mask (1019055)
K252093 · OHS
Merchsource, LLC
General & Plastic Surgery · 105d
Cleared Oct 16, 2025
NeurAxis IB-Stim (01-1020)
K252024 · QHH
Neuraxis
Gastroenterology & Urology · 108d
Cleared Oct 16, 2025
Arthrex Synergy Vision Imaging System
K251994 · GCJ
Arthrex, Inc.
General & Plastic Surgery · 111d
Cleared Oct 16, 2025
Uterine Aspiration Set
K251882 · HHK
Gcmedica Enterprise Ltd.(Wuxi)
Obstetrics & Gynecology · 118d
Cleared Oct 16, 2025
Elos Accurate Hybrid Base
K251497 · NHA
Elos Medtech Pinol A/S
Dental · 154d
Cleared Oct 16, 2025
Coolfase
K250852 · GEI
Asterasys Co., Ltd.
General & Plastic Surgery · 209d
Cleared Oct 16, 2025
MateLaser Medical Diode Laser Systems (ML-DLS-30)
K250731 · NVK
Matelaser, Inc.
Dental · 219d
Cleared Oct 16, 2025
Re:Balans
K243727 · DSB
Mode Sensors AS
Cardiovascular · 317d
Cleared Oct 16, 2025
SurgiAid Collagen Wound Dressing (HA)
K242100 · KGN
Maxigen Biotech, Inc.
General & Plastic Surgery · 455d
Cleared Oct 15, 2025
TargetCool-e
K253348 · GEH
Recensmedical, Inc.
General & Plastic Surgery · 15d
Cleared Oct 15, 2025
BioBrace® Extra-Articular Ligament Augmentation Kit
K252946 · MAI
Conmed Corporation
Orthopedic · 30d
Cleared Oct 15, 2025
LOCATOR® Angled Abutment
K252944 · NHA
Zest Anchors, LLC
Dental · 30d
Cleared Oct 15, 2025
ELEOS™ Limb Salvage System with NanoCept® Technology
K252920 · QZZ
Onkos Surgical, Inc.
Orthopedic · 33d