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
5521–5544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 2024
Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX)
K243306 · QRL
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 25d
Cleared Nov 15, 2024
ACUSON Redwood Diagnostic Ultrasound System
K243299 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Nov 15, 2024
TMINI Miniature Robotic System
K243285 · OLO
THINK Surgical, Inc.
Orthopedic · 28d
Cleared Nov 15, 2024
AdVance™ XP Male Sling System (720163-03)
K242960 · OTM
Boston Scientific Corporation
Gastroenterology & Urology · 51d
Cleared Nov 15, 2024
The 5000 Compact Series Ultrasound Systems
K242800 · IYN
Philips Ultrasound, LLC
Radiology · 59d
Cleared Nov 15, 2024
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
K242465 · QOF
Hologic, Inc.
Microbiology · 87d
Cleared Nov 15, 2024
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
K242419 · LIT
Creagh Medical Ltd. Dba Surmodics, Inc.
Cardiovascular · 92d
Cleared Nov 15, 2024
Speedex Light Body
K242360 · ELW
Dent4you AG
Dental · 98d
Cleared Nov 15, 2024
CORIOGRAPH Pre-Op Planning and Modeling Services
K242272
Blue Belt Technologies, Inc.
Orthopedic · 106d
Cleared Nov 15, 2024
aprevo® Cervical ACDF
K242260 · ODP
Carlsmed, Inc.
Orthopedic · 107d
Cleared Nov 15, 2024
Koios DS
K242130 · POK
Koios Medical, Inc.
Radiology · 116d
Cleared Nov 15, 2024
1CMR Pro
K242062 · LLZ
Mycardium AI Limited
Radiology · 123d
Cleared Nov 15, 2024
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
K241439 · QFM
Vuno, Inc.
Radiology · 178d
Cleared Nov 15, 2024
Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ...
K241224 · NLH
Surgical Instrument Service and...
Cardiovascular · 197d
Cleared Nov 15, 2024
ArtiSeal Vessel Sealing System-ArtiSeal Instruments
K241138 · GEI
Livsmed, Inc.
General & Plastic Surgery · 205d
Cleared Nov 15, 2024
VIVIX-S 1751S
K241125 · MQB
Vieworks Co., Ltd.
Radiology · 206d
Cleared Nov 15, 2024
Gelsoft™ Plus Vascular Prostheses
K241070 · DSY
Vascutek, Ltd.
Cardiovascular · 210d
Cleared Nov 15, 2024
EchoGo Amyloidosis (1.0)
K240860 · SDJ
Ultromics Limited
Cardiovascular · 232d
Cleared Nov 15, 2024
b-ONE® Total Hip System
K240528 · LZO
B-One Ortho, Corp.
Orthopedic · 266d
Cleared Nov 15, 2024
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G),...
K240523 · MQE
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 266d
Cleared Nov 15, 2024
NUVENTUS NV.C™ Dental Implant System
K233081 · DZE
Infinitum Eta, Ltd.
Dental · 416d
Cleared Nov 14, 2024
Xrecovery (XR-001)
K242940 · IRP
Shenzhen Xinrun Electric Appliances...
Physical Medicine · 50d
Cleared Nov 14, 2024
Tandry Q-Locking Plate System
K242814 · HRS
Microware Precision Co., Ltd.
Orthopedic · 57d
Cleared Nov 14, 2024
DEFINE System (AG612444A)
K242598 · PBX
Inmode , Ltd.
General & Plastic Surgery · 76d