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
5737–5760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 2024
Calibrate LTX Interbody System
K242147 · MAX
Alphatec Spine, Inc.
Orthopedic · 59d
Cleared Sep 20, 2024
Air Powered Tooth Polishing System (Perio-Mate)
K241880 · EFB
Nakanishi, Inc.
Dental · 84d
Cleared Sep 20, 2024
Microwave Ablation Antennas
K241825 · NEY
Canyon Medical, Inc.
General & Plastic Surgery · 88d
Cleared Sep 20, 2024
Luer Lock Syringe with Safety Needle
K241821 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 88d
Cleared Sep 20, 2024
aprevo® anterior and lateral lumbar interbody fusion device
K241332 · MAX
Carlsmed, Inc.
Orthopedic · 133d
Cleared Sep 20, 2024
Derma-R Cream (Derma-R Cream)
K240722 · FRO
Raya Pharmaceuticals, LLC
General & Plastic Surgery · 186d
Cleared Sep 20, 2024
MTONE EVO (MTONE EVO)
K240604 · GEX
M&T S.R.L.
General & Plastic Surgery · 200d
Cleared Sep 20, 2024
NeuroField Analysis Suite
K240420 · OLU
Neurofield, Inc.
Neurology · 220d
Cleared Sep 20, 2024
TRIGEN MAX Tibial Nail System
K240061 · JDS
Smith & Nephew, Inc.
Orthopedic · 255d
Cleared Sep 20, 2024
PIUR tUS Infinity
K240036 · QIH
Piur Imaging GmbH
Radiology · 259d
Cleared Sep 20, 2024
Ecomed Disposable Administration Sets
K234129 · FPA
Ecomed Solutions, LLC
General Hospital · 267d
Cleared Sep 20, 2024
ERI Portable X-ray System (CVX-air)
K234108 · IZL
Energy Resources International Co., Ltd.
Radiology · 268d
Cleared Sep 20, 2024
Traus SSG10 Surgical System
K233153 · HBC
Saeshin Precision Co., Ltd.
Neurology · 359d
Cleared Sep 20, 2024
HiCardi+ H100
K232670 · DSH
MEZOO Co., Ltd.
Cardiovascular · 385d
Cleared Sep 19, 2024
HAnano InterFuse(R) Modular Interbody
K242509 · MAX
Next Orthosurgical
Orthopedic · 28d
Cleared Sep 19, 2024
GF85 (models GF85-3P, GF85-SP)
K242478 · KPR
Samsung Electronics Co., Ltd.
Radiology · 29d
Cleared Sep 19, 2024
Sterile and Non-Sterile Ultrasonic Coupling Agent
K242167 · MUI
Anhui Deepblue Medical Technology...
Radiology · 57d
Cleared Sep 19, 2024
Coconut Hybrid
K242162 · NUC
Good Clean Love, Inc.
Obstetrics & Gynecology · 57d
Cleared Sep 19, 2024
Pectus Blu Support Bar System
K241709 · HRS
Biomet Microfixation
Orthopedic · 98d
Cleared Sep 19, 2024
Midas Flowmeter
K241465 · BZR
Parker Hannifin Corporation
Anesthesiology · 119d
Cleared Sep 19, 2024
Stethophone
K240901 · DQD
Sparrow Acoustics, Inc.
Cardiovascular · 170d
Cleared Sep 19, 2024
Star E900 Handpiece Series
K240183 · EGS
Dentalez, Inc., Stardental Division
Dental · 240d
Cleared Sep 19, 2024
MonoStereo
K234096 · EOB
Medicaltek Co., Ltd.
Ear, Nose, Throat · 268d
Cleared Sep 18, 2024
Arrow® Nitinol Wire
K241784 · DQX
Teleflex Medical
Cardiovascular · 90d