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
6793–6816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2024
Safety Lancet (XXXV)
K241627 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 14d
Cleared Jun 20, 2024
Shoreline ACS Interbody System
K241466 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 28d
Cleared Jun 20, 2024
Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue
K241435 · MBI
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Jun 20, 2024
Reef TO/TA System
K240830 · MAX
Orthofix Medical, Inc.
Orthopedic · 86d
Cleared Jun 20, 2024
RODIN Titan 3D Resin
K240688 · EBI
Belport Company, Inc., Gingi-Pak
Dental · 99d
Cleared Jun 20, 2024
Electric wheelchair
K240673 · ITI
Zhejiang Hfizer Medical Equipment...
Physical Medicine · 101d
Cleared Jun 20, 2024
ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System
K240669 · JWH
Globus Medical, Inc.
Orthopedic · 101d
Cleared Jun 20, 2024
SMART Bun-Yo-Matic CT
K240642 · QIH
Disior, Ltd.
Radiology · 106d
Cleared Jun 20, 2024
APTUS Elbow Dorsal Olecranon Plates
K240613 · HRS
Medartis AG
Orthopedic · 107d
Cleared Jun 20, 2024
IVYLASER Diode laser hair removal system (IVY-HR-Alloy)
K240611 · GEX
Ivylaser (Beijing) Technology Co.,Ltd
General & Plastic Surgery · 107d
Cleared Jun 20, 2024
SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit,...
K233225 · GCJ
Schoelly Fiberoptic GmbH
General & Plastic Surgery · 266d
Cleared Jun 20, 2024
Freedom Peripheral Nerve Stimulator (PNS) System
K233162 · GZF
Curonix
Neurology · 267d
Cleared Jun 20, 2024
Copra Smile, Copra Supreme Hyperion
K233158 · EIH
Whitepeaks Dental Solutions GmbH
Dental · 267d
Cleared Jun 20, 2024
Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
K233117 · EBW
Nakanishi, Inc.
Dental · 267d
Cleared Jun 20, 2024
DeepRhythm Platform
K232161 · DPS
Medicalgorithmics S.A.
Cardiovascular · 336d
Cleared Jun 20, 2024
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
K230675 · SAN
Specific Diagnostics, LLC
Microbiology · 468d
Cleared Jun 19, 2024
EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
K232997 · FDS
Olympus Medical Systems Corporation
Gastroenterology & Urology · 271d
Cleared Jun 18, 2024
Invisalign System
K241412 · NXC
Align Technology, Inc.
Dental · 32d
Cleared Jun 18, 2024
Pen Injector
K240774 · FMF
Wuxi Nest Biotechnology Co., Ltd.
General Hospital · 89d
Cleared Jun 18, 2024
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and...
K240678 · MBH
Depuy Ireland UC
Orthopedic · 99d
Cleared Jun 18, 2024
IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B,...
K240583 · OHT
Shenzhen Beauty Every Moment...
General & Plastic Surgery · 109d
Cleared Jun 18, 2024
Irrisept Antimicrobial Wound Lavage
K240552 · FRO
Irrimax Corporation
General & Plastic Surgery · 111d
Cleared Jun 18, 2024
Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)
K240196 · GCJ
Yuwonmeditech Co., Ltd.
General & Plastic Surgery · 145d
Cleared Jun 18, 2024
Fitbone Trochanteric
K233867 · HSB
Orthofix Srl
Orthopedic · 195d