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
12193–12216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2022
Digital Radiography CXDI-Pro, Digital Radiography D1
K222855 · MQB
Canon, Inc.
Radiology · 26d
Cleared Oct 16, 2022
STIMPOD NMS450 Nerve Stimulator
K213049 · BXN
Xavant Technology (Pty), Ltd.
Anesthesiology · 389d
Cleared Oct 16, 2022
LUDWIG Electrosurgical Device
K221574 · GEI
Aesthetics Biomedical
General & Plastic Surgery · 137d
Cleared Oct 16, 2022
Pulse Oximeter (Model C101A2, C101B1, C101A3)
K221979 · DQA
Shenzhen Imdk Medical Technology Co.,...
Anesthesiology · 103d
Cleared Oct 16, 2022
SafeBreak Vascular
K222791 · QOI
Lineus Medical, LLC
General Hospital · 31d
Cleared Oct 15, 2022
CONDUIT Cages
K222276 · ODP
Depuy Spine
Orthopedic · 78d
Cleared Oct 14, 2022
Safety Insulin Pen Needles
K213183 · FMI
Zhejiang Kindly Medical Devices Co.,...
General Hospital · 380d
Cleared Oct 14, 2022
CoreLevee
K213748 · NGX
Lutronic Corporation
Physical Medicine · 318d
Cleared Oct 14, 2022
HeartFlow Analysis
K213857 · PJA
HeartFlow, Inc.
Cardiovascular · 308d
Cleared Oct 14, 2022
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied...
K214054 · DYH
Tp Orthodontics, Inc.
Dental · 291d
Cleared Oct 14, 2022
PAL Infiltration System
K220318 · QPB
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 253d
Cleared Oct 14, 2022
Tornier Perform Humeral System – Fracture
K220914 · PHX
Tornier, Inc.
Orthopedic · 198d
Cleared Oct 14, 2022
Shoulder PacemakerTM
K220994 · IPF
Ncs Lab Srl
Physical Medicine · 193d
Cleared Oct 14, 2022
X-CUBE 70, X-CUBE 90
K221093 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 184d
Cleared Oct 14, 2022
FOCUS Interbody System
K221172 · MAX
Oc Medical Devices
Orthopedic · 172d
Cleared Oct 14, 2022
AI-Rad Companion Organs RT
K221305 · QKB
Siemens Medical Solutions USA, Inc.
Radiology · 162d
Cleared Oct 14, 2022
Southern Anterior Screw Fixated Cage (SASCA)
K221447 · OVD
Southern Medical (Pty) , Ltd.
Orthopedic · 149d
Cleared Oct 14, 2022
syngo.via View&GO
K221501 · LLZ
Siemens Healthcare GmbH
Radiology · 144d
Cleared Oct 14, 2022
BD Surgiphor™ Antimicrobial Irrigation System
K221504 · FQH
Bd
General & Plastic Surgery · 144d
Cleared Oct 14, 2022
Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
K221840 · JXG
Integra Lifesciences Production...
Neurology · 112d
Cleared Oct 14, 2022
ZSFab Lumbar Interbody System
K221858 · MAX
Zsfab, Inc.
Orthopedic · 109d
Cleared Oct 14, 2022
Sublime Microcatheter
K221886 · DQY
Surmodics,Inc.
Cardiovascular · 107d
Cleared Oct 14, 2022
Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)
K222284 · GEI
Applied Medical Resources Corporation
General & Plastic Surgery · 74d
Cleared Oct 14, 2022
16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast...
K222407 · MOS
Neocoil, LLC
Radiology · 66d