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
3481–3504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 2025
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and...
K251397 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 29d
Cleared Jun 04, 2025
0184 CO2 Sampling line
K251216 · CCK
Barbaras Development, Inc.
Anesthesiology · 47d
Cleared Jun 04, 2025
Blood collection tube holders
K250961 · JKA
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 65d
Cleared Jun 04, 2025
Paradigm System
K250879 · OLO
Proprio, Inc.
Orthopedic · 72d
Cleared Jun 04, 2025
ID LIGHT CURE SYSTEM
K250804 · EBD
Id Korea Co., Ltd.
Dental · 79d
Cleared Jun 04, 2025
PhysCade System
K250749 · DQK
Physcade, Inc.
Cardiovascular · 84d
Cleared Jun 04, 2025
TeleRehab Aermos Cardiopulmonary Rehabilitation
K250259 · DRG
The ScottCare Corporation
Cardiovascular · 127d
Cleared Jun 04, 2025
Disposable Balloon Catheter B5-2C
K250118 · EOQ
Olympus Medical Systems Corporation
Anesthesiology · 139d
Cleared Jun 04, 2025
Tendon Protect (50242)
K243843 · OWY
Kerecis Limited
Orthopedic · 173d
Cleared Jun 04, 2025
TraumaCad Neo (1.1)
K243810 · QIH
Brainlab , Ltd.
Radiology · 175d
Cleared Jun 04, 2025
NG-Test® CTX-M MULTI
K243499 · PTJ
Ng Biotech
Microbiology · 204d
Cleared Jun 04, 2025
Montblanc Plate System
K243368 · HRS
Medifield Medical Co., Ltd.
Orthopedic · 217d
Cleared Jun 04, 2025
LubriZenzs
K242712 · NUC
Sk Zen, LLC
Obstetrics & Gynecology · 268d
Cleared Jun 04, 2025
EVE Synergy (EVE-20M)
K241433 · IPF
Weero Co., Ltd.
Neurology · 379d
Cleared Jun 04, 2025
Ultrasound Stimulator
K240788 · IMI
Jkh Health Co., Ltd.
Physical Medicine · 439d
Cleared Jun 03, 2025
PENTAX Medical Video Processor (EPK-i8020c)
K251127 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 53d
Cleared Jun 03, 2025
DISINTEK™ PA Test Strips
K251035 · JOJ
Serim Research
General Hospital · 61d
Cleared Jun 03, 2025
BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™...
K250682 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 89d
Cleared Jun 03, 2025
gi2000 Electrosurgical Generator
K250657 · GEI
Cintron Medical Corporation
General & Plastic Surgery · 90d
Cleared Jun 03, 2025
Endoform Reconstructive Template - PLGA
K250598 · FTM
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 95d
Cleared Jun 03, 2025
Globe Introducer (601-01001)
K250529 · DRA
Kardium, Inc.
Cardiovascular · 99d
Cleared Jun 03, 2025
Patriot SI Implant System
K250001 · OUR
Spinal Simplicity, LLC
Orthopedic · 152d
Cleared Jun 03, 2025
Raptor Aspiration Catheter
K243948 · NRY
Balt USA, LLC
Neurology · 162d
Cleared Jun 03, 2025
GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for...
K243796 · LZA
Glove One, LLC
General Hospital · 175d