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
1873–1896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 2025
Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909,...
K252142 · OHS
Shenzhen Siken 3D Technology...
General & Plastic Surgery · 150d
Cleared Dec 05, 2025
Velora Acetabular System
K252067 · LPH
Restor3D, Inc.
Orthopedic · 157d
Cleared Dec 05, 2025
KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)
K251731 · EOQ
Karl Storz SE & CO. KG
Ear, Nose, Throat · 182d
Cleared Dec 05, 2025
ProSeal™ Transfer Injector (421120, 421130, 421140)
K251722 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 184d
Cleared Dec 05, 2025
Personalized Therapy Comfort Settings (PTCS)
K251657 · BZD
ResMed Corp
Anesthesiology · 189d
Cleared Dec 05, 2025
Overjet CBCT Assist
K251514 · QIH
Overjet, Inc.
Radiology · 203d
Cleared Dec 05, 2025
Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr...
K251403 · FAS
Dornier Medtech America Inc (Dmta)
Gastroenterology & Urology · 213d
Cleared Dec 05, 2025
Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
K251337 · JTN
Thermo Fisher Scientific (Oxoid Ltd.)
Microbiology · 219d
Cleared Dec 05, 2025
PUREVUE™ FMS
K250795 · HRX
W.O.M. World of Medicine GmbH
Orthopedic · 266d
Cleared Dec 05, 2025
ARTAssistant
K250780 · QKB
Manteia Technologies Co., Ltd.
Radiology · 266d
Cleared Dec 05, 2025
SpineLinc Anterior Cervical Implant System
K250764 · ODP
Lincotek Medical
Orthopedic · 267d
Cleared Dec 05, 2025
Remvia NightGuard
K250743 · MQC
Remvia
Dental · 269d
Cleared Dec 05, 2025
VSP Orthopedics System
K250711 · PBF
3D Systems, Inc.
Orthopedic · 270d
Cleared Dec 05, 2025
Augmented Gingival Matrix
K250512 · NPL
Neo Modulus (Suzhou) Medical Sci-Tech...
Dental · 287d
Cleared Dec 05, 2025
MEMO Patch M (MPT-E08R-UNC01)
K243438 · DXH
Huinno Co., Ltd.
Cardiovascular · 394d
Cleared Dec 04, 2025
Tigon Medical Knotless and Dual Javelin All-Suture Anchors
K252596 · MBI
Tigon Medical
Orthopedic · 111d
Cleared Dec 04, 2025
Mobility Scooter (T5)
K252588 · INI
Zhejiang Taotao Vehicle Co., Ltd.
Physical Medicine · 111d
Cleared Dec 04, 2025
Vektor Computational ECG Mapping System (vMap®)
K252429 · DQK
Vektor Medical, Inc.
Cardiovascular · 125d
Cleared Dec 04, 2025
MitraPatch Mitral Valve Repair System
K252126 · PAW
Chawla Heart Technologies, LLC
Cardiovascular · 150d
Cleared Dec 04, 2025
Spineology Navigation Instruments
K251943 · OLO
Spineology, Inc.
Orthopedic · 163d
Cleared Dec 04, 2025
nSet+ Stabilization Set [6426733]
K251257 · FPA
Np Medical
General Hospital · 225d
Cleared Dec 04, 2025
ADVIA Centaur Anti-Thyroglobulin II (aTgII)
K250816 · JNL
Siemens Healthcare Diagnostics, Inc.
Immunology · 261d
Cleared Dec 04, 2025
ASUS Ultrasound Imaging System (LU800 series)
K250791 · IYN
Asustek Computer, Inc.
Radiology · 265d
Cleared Dec 04, 2025
FFX Facet Fixation System
K250679 · MRW
Sc Medica
Orthopedic · 273d