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
11905–11928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2022
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
K222721 · LZA
Safeskin Retailing (Hk) Limited
General Hospital · 40d
Cleared Oct 17, 2022
CASSATT™ SIJ Fixation System
K211785 · OUR
Ctl Medical Corporation
Orthopedic · 495d
Cleared Oct 17, 2022
ATTUNE Revision Cones
K212746 · MBH
Depuy Ireland UC
Orthopedic · 413d
Cleared Oct 17, 2022
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
K221014 · NFB
Effortless Oxygen, LLC
Anesthesiology · 195d
Cleared Oct 17, 2022
Multi-Lancet Device 2, ReliOn Premier Lancing Device
K221175 · QRL
Arkray, Inc.
General & Plastic Surgery · 175d
Cleared Oct 17, 2022
Disposable Syringe with permanently attached needle, Safety Syringe with...
K221308 · FMF
Jiangxi Maidikang Medical Devices...
General Hospital · 165d
Cleared Oct 17, 2022
YUWELL Electronic Blood Pressure Monitor
K221372 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 158d
Cleared Oct 17, 2022
Standalone ALIF Interbody Fusion System
K221936 · OVD
Eminent Spine
Orthopedic · 108d
Cleared Oct 17, 2022
Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet...
K222074 · LZA
Zibo Langu New Material Technology...
General Hospital · 95d
Cleared Oct 17, 2022
AcQMap High Resolution Imaging and Mapping System
K222209 · DQK
Acutus Medical, Inc.
Cardiovascular · 84d
Cleared Oct 17, 2022
Mobility Scooter, Model: W3331F
K222495 · INI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 60d
Cleared Oct 17, 2022
Zimmer Persona Personalized Knee System
K222566 · MBH
Zimmer, Inc.
Orthopedic · 54d
Cleared Oct 17, 2022
WavelinQ™ Generator
K222793 · GEI
C.R. Bard, Inc.
General & Plastic Surgery · 31d
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