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
12265–12288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 2022
Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper...
K213610 · GEI
Katalyst Surgical, LLC
General & Plastic Surgery · 326d
Cleared Oct 07, 2022
VisionAir Patient-Specific Airway Stent
K213969 · NWA
New Cos Inc. Dba Visionair Solutions
Anesthesiology · 291d
Cleared Oct 07, 2022
Disposable Sterile Syringe with permanently attached needle
K220057 · MEG
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 274d
Cleared Oct 07, 2022
YADU Surgical Gowns
K220092 · FYA
Henan Yadu Industrial Co., Ltd.
General Hospital · 268d
Cleared Oct 07, 2022
RespiraSense
K220111 · BZQ
Pmd Solutions
Anesthesiology · 267d
Cleared Oct 07, 2022
Electrically Powered Wheelchair, Joy Rider
K220156 · ITI
Tung Keng Enterprise Co., Ltd.
Physical Medicine · 261d
Cleared Oct 07, 2022
MIM-Ablation
K220256 · QTZ
Mim Software, Inc.
Radiology · 249d
Cleared Oct 07, 2022
AMSafe NeuFlo Needleless Connector
K220267 · FPA
Amsino International, Inc.
General Hospital · 249d
Cleared Oct 07, 2022
BriefCase
K220709 · QAS
Aidoc Medical , Ltd.
Radiology · 211d
Cleared Oct 07, 2022
Infant Heel WarmerTM
K221154 · MPO
International Biomedical
Physical Medicine · 169d
Cleared Oct 07, 2022
Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105,...
K221170 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 168d
Cleared Oct 07, 2022
Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing
K221310 · OCX
Changzhou Endoclean Medical Device...
Gastroenterology & Urology · 155d
Cleared Oct 07, 2022
SteriTite Container System with MediTray Parts
K221492 · KCT
Case Medical, Inc.
General Hospital · 137d
Cleared Oct 07, 2022
Miha Bodytec II
K221498 · NGX
Miha Bodytec GmbH
Physical Medicine · 137d
Cleared Oct 07, 2022
Pre-Formed Blue
K221575 · DQX
Lake Region Medical
Cardiovascular · 128d
Cleared Oct 07, 2022
InBody Blood pressure monitor, Model BPBIO480KV
K221764 · DXN
Inbody Co., Ltd.
Cardiovascular · 112d
Cleared Oct 07, 2022
Rebellion
K221818 · HAE
Morpheus AG
Neurology · 106d
Cleared Oct 07, 2022
IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System,...
K222028 · MAX
Alphatec Spine
Orthopedic · 88d
Cleared Oct 07, 2022
Cold Sore Device (Model: QPZ-01)
K222205 · OKJ
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 74d
Cleared Oct 07, 2022
PURE Laser
K222369 · GEX
Endymed Medical, Ltd.
General & Plastic Surgery · 63d
Cleared Oct 07, 2022
Nuvola
K222418 · NXC
Gruppo Europeo Ortodonzia Srl
Dental · 58d
Cleared Oct 07, 2022
Protect-It Custom Fit Dental Guard
K222424 · OBR
Doc Brands, Inc.
Dental · 57d
Cleared Oct 07, 2022
CUVIS-spine
K222698 · OLO
Curexo, Inc.
Orthopedic · 30d
Cleared Oct 07, 2022
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy...
K222714 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 29d