FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
17473–17496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 2021
Velocity Alpha Highspeed Surgical Drill System
K191479 · HBE
Adeor Medical AG
Neurology · 677d
Cleared Apr 11, 2021
Medical Surgical Mask (Non-sterile)
K202761 · FXX
Guangdong Goodfeeling Hygiene...
General Hospital · 202d
Cleared Apr 11, 2021
Surgical Mask
K203012 · FXX
Customfab, Inc.
General Hospital · 192d
Cleared Apr 11, 2021
Disposable Medical Mask
K210018 · FXX
Diasia Biomedical Technology Co., Ltd.
General Hospital · 97d
Cleared Apr 09, 2021
hekaDrill
K193630 · HBC
Zethon, Ltd.
Neurology · 470d
Cleared Apr 09, 2021
PuRE PMMA Disc
K201563 · EBG
Quest Dental USA Corp.
Dental · 303d
Cleared Apr 09, 2021
Electric breast pump (Models: RH-228 and RH-338)
K201903 · HGX
Cixi Ruihong Electric Appliance Co.,...
Obstetrics & Gynecology · 275d
Cleared Apr 09, 2021
DeepLook PRECISE
K202084 · LLZ
Deeplook, Inc.
Radiology · 256d
Cleared Apr 09, 2021
EasyPoint Blood Collection Plus
K202325 · JKA
Retractable Technologies, Inc.
General Hospital · 235d
Cleared Apr 09, 2021
Disposable Medical Face Mask-Model FM-04
K202513 · FXX
Shenzhen Jinko Industrial Co., Ltd.
General Hospital · 221d
Cleared Apr 09, 2021
Enteral Feeding Catheter
K202748 · KNT
Medcaptain Life Science Co., Ltd.
Gastroenterology & Urology · 200d
Cleared Apr 09, 2021
KeyPrint KeySplint Hard
K203000 · MQC
Mycone Dental Supply Co. Inc. (Dba...
Dental · 190d
Cleared Apr 09, 2021
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K203571 · HQD
Acuity Polymers, Inc.
Ophthalmic · 123d
Cleared Apr 09, 2021
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS,...
K203681 · MUJ
Brainlab AG
Radiology · 113d
Cleared Apr 09, 2021
IdentiTi ALIF Standalone Interbody System
K203742 · OVD
Alphatec Spine, Inc.
Orthopedic · 108d
Cleared Apr 09, 2021
HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System
K210068 · IYN
Samsung Medison Co., Ltd.
Radiology · 88d
Cleared Apr 09, 2021
Endoscope Model EI-740D/S
K210162 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 78d
Cleared Apr 09, 2021
HYPER Focus
K210418 · KPS
Shanghai United Imaging Healthcare...
Radiology · 57d
Cleared Apr 09, 2021
PENTAX Medical Video Duedenoscope ED34-i10T2
K210710 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 30d
Cleared Apr 08, 2021
Well Lead All Silicone Foley Catheter with Temperature Sensor
K202134 · EZL
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 251d
Cleared Apr 08, 2021
Electric wheelchair (S7204/S7205)
K202632 · ITI
Dongguan Prestige Sporting Goods Co.,...
Physical Medicine · 209d
Cleared Apr 08, 2021
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K202729 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 202d
Cleared Apr 08, 2021
Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa...
K202785 · IYN
Shenzhen Mindray Bio-Meidcal...
Radiology · 198d
Cleared Apr 08, 2021
ActivSight Intraoperative Imaging System
K203550 · OWN
Activ Surgical, Inc.
General & Plastic Surgery · 125d