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
12673–12696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2022
GlucoSure Link Blood Glucose Monitoring System
K212140 · NBW
Apex BioTechnology Corp.
Chemistry · 413d
Cleared Aug 25, 2022
Apollo Duet (Model : APD-4000)
K212253 · PBX
Weero Co.
General & Plastic Surgery · 402d
Cleared Aug 25, 2022
ONX Large External Fixation System
K213905 · KTT
Orthonovis, Inc.
Orthopedic · 254d
Cleared Aug 25, 2022
Disposable, vinyl examination gloves, Yellow
K220055 · LYZ
Dezhou Hengchang Medical Technology...
General Hospital · 231d
Cleared Aug 25, 2022
Nitrile Exam Gloves (Blue, Black)
K221143 · LZA
Hebei Astro Medical Supply Co., Ltd.
General Hospital · 127d
Cleared Aug 25, 2022
Compass Steerable Needle
K221206 · KTI
Serpex Medical, Inc.
Anesthesiology · 121d
Cleared Aug 25, 2022
CONDUIT Lateral Switch Plate
K221325 · MAX
Medos International SARL
Orthopedic · 111d
Cleared Aug 25, 2022
LapBox Tissue Containment Removal System
K221365 · GCJ
Ark Surgical, Ltd.
General & Plastic Surgery · 105d
Cleared Aug 25, 2022
Iconic Latex Glove
K221648 · LYY
Iconic Medicare Sdn Bhd
General Hospital · 79d
Cleared Aug 25, 2022
Acute QC Strut and Components
K221792 · OSN
Smith & Nephew, Inc.
Orthopedic · 65d
Cleared Aug 25, 2022
LINQ II Insertable Cardiac Monitor
K221962 · MXD
Medtronic, Inc.
Cardiovascular · 51d
Cleared Aug 25, 2022
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization...
K222543 · NVE
Steris
General Hospital · 3d
Cleared Aug 24, 2022
The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant...
K211771 · FXX
The Good Corporation
General Hospital · 442d
Cleared Aug 24, 2022
TightRail Guardian Motorized Dilator Sheath
K212784 · DRE
Spectranetics, Inc.
Cardiovascular · 357d
Cleared Aug 24, 2022
AutoContour Model RADAC V2
K220598 · QKB
Radformation, Inc.
Radiology · 175d
Cleared Aug 24, 2022
Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
K220998 · NUH
Shenzhen Kentro Medical Electronics...
Physical Medicine · 142d
Cleared Aug 24, 2022
V-Laser
K221427 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 100d
Cleared Aug 24, 2022
ARIX Small Fragment System
K221920 · HRS
Jeil Medical Corporation
Orthopedic · 54d
Cleared Aug 24, 2022
ivWatch Model 400
K222212 · PMS
Ivwatch, LLC
General Hospital · 30d
Cleared Aug 24, 2022
NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System,...
K222230 · OBP
Neuronetics, Inc.
Neurology · 30d
Cleared Aug 24, 2022
Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
K222232 · LJS
Bard Access Systems, Inc.
General Hospital · 30d
Cleared Aug 24, 2022
miCOR System Lens Fragmentation System
K222236 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 29d
Cleared Aug 23, 2022
2.1 x 255mm Drill, 22mm Stop
K213072 · HBE
Biomet Micofixation
Neurology · 334d
Cleared Aug 23, 2022
FIBERGRAFT Aeridyan Matrix Bone Graft Substitute
K213803 · MQV
Prosidyan, Inc.
Orthopedic · 260d