FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
6505–6528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2024
Single use flexible ureteroscope (UR-D1)
K240074 · FGB
Shenzhen Besdata Technology Co., Ltd.
Gastroenterology & Urology · 268d
Cleared Oct 03, 2024
Curlin 8000 Ambulatory Infusion System
K242660 · FRN
Zevex, Inc.
General Hospital · 29d
Cleared Oct 03, 2024
Lantern® Hip
K242616 · ONN
Orthalign, Inc.
Orthopedic · 30d
Cleared Oct 03, 2024
OBSIDIO™ Conformable Embolic
K242507 · KRD
Boston Scientific
Cardiovascular · 42d
Cleared Oct 03, 2024
Injectable Root Canal Bioceramic Sealer (i-MTA SP)
K241977 · KIF
Longly Biotechnology (Wuhan) Co., Ltd.
Dental · 90d
Cleared Oct 03, 2024
Icona Hip Stem
K241472 · MEH
Corin U.S.A. Limited
Orthopedic · 132d
Cleared Oct 03, 2024
Pulse Oximeter (WS20A)
K240808 · DQA
Hunan Accurate Bio-Medical Technology...
Anesthesiology · 192d
Cleared Oct 03, 2024
Additive Manufacturing Zirconia Customized Restoration
K240586 · ELL
Hangzhou Thales Medtech Co., Ltd.
Dental · 216d
Cleared Oct 03, 2024
Exactech® TRULIANT® Knee System
K240393 · MBH
Exactech, Inc.
Orthopedic · 238d
Cleared Oct 03, 2024
Rest Assure System
K233497 · PLC
Somnomed, Inc.
Dental · 338d
Cleared Oct 02, 2024
NxTAG® Respiratory Pathogen Panel
K242613 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 29d
Cleared Oct 02, 2024
REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component
K242377 · JWH
Osteoremedies, LLC
Orthopedic · 54d
Cleared Oct 02, 2024
RejuvaKnee™ Collagen Meniscus Implant
K242302 · OLC
Collagen Matrix, Inc.
Orthopedic · 58d
Cleared Oct 02, 2024
Versana Premier
K242005 · IYN
GE Medical Systems Ultrasound and...
Radiology · 85d
Cleared Oct 02, 2024
VitruvianScan (v1.0)
K241925 · LNH
Perspectum, Ltd.
Radiology · 93d
Cleared Oct 02, 2024
Anovo Surgical System (model 6N)
K241907 · QNM
Momentis Surgical , Ltd.
General & Plastic Surgery · 93d
Cleared Oct 02, 2024
MammoScreen BD
K241561 · QIH
Therapixel
Radiology · 124d
Cleared Oct 02, 2024
Interwedge® Standalone Lateral
K241487 · OVD
Foundation Surgical Group, Inc.
Orthopedic · 131d
Cleared Oct 02, 2024
Arthrex Virtual Implant Positioning (VIP) System Software
K241097 · QHE
Arthrex, Inc.
Orthopedic · 163d
Cleared Oct 02, 2024
ARTFX Lumbar PEEK Cages
K240889 · MAX
Artfx Medical
Orthopedic · 184d
Cleared Oct 02, 2024
8F Modified Sheath System
K240529 · QJP
Route 92 Medical, Inc.
Neurology · 222d
Cleared Oct 02, 2024
Ceramic Etchant (HF-5 and HF-9)
K240153 · KLE
Liaoning Upcera Co., Ltd.
Dental · 257d
Cleared Oct 01, 2024
Definium Pace Select ET
K242678 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 25d
Cleared Oct 01, 2024
GM85
K242651 · IZL
Samsung Electronics Co., Ltd.
Radiology · 27d