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
12241–12264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 2022
Auto Folding Scooter, S21F
K220227 · INI
Heartway Medical Products Co., Ltd.
Physical Medicine · 258d
Cleared Oct 12, 2022
Elecsys CMV IgG
K220911 · LFZ
Roche Diagnostics
Microbiology · 197d
Cleared Oct 12, 2022
Elecsys HSV-1 IgG (08948844160)
K220923 · MXJ
Roche Diagnostics
Microbiology · 195d
Cleared Oct 12, 2022
Elecsys HSV-2 IgG (08948887160)
K220924 · MYF
Roche Diagnostics
Microbiology · 195d
Cleared Oct 12, 2022
Aqua Naina Plus Sterile Saline Solution
K221263 · LPN
Chemtex USA, Inc.
Ophthalmic · 163d
Cleared Oct 12, 2022
TrusFIL-Flow Flowable Composite Restorative
K221510 · EBF
Rizhao Huge Biomaterials Company, Ltd.
Dental · 141d
Cleared Oct 12, 2022
Ameda Pearl Electric Breast Pump
K221576 · HGX
Ameda, Inc.
Obstetrics & Gynecology · 133d
Cleared Oct 12, 2022
Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
K221712 · GEX
Fotona D.O.O.
General & Plastic Surgery · 121d
Cleared Oct 12, 2022
Arm Blood Pressure Monitor
K221913 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 104d
Cleared Oct 12, 2022
The Alma Soprano Titanium
K222064 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 91d
Cleared Oct 12, 2022
Durex Penck III Regular
K222068 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 90d
Cleared Oct 11, 2022
AAMI4 Isolation Gown
K214116 · FYC
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital · 285d
Cleared Oct 11, 2022
SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L,...
K220169 · IYN
Bionet Co., Ltd.
Radiology · 264d
Cleared Oct 11, 2022
Apyx One Console
K221830 · GEI
Apyx Medical Corporation
General & Plastic Surgery · 110d
Cleared Oct 11, 2022
Branchor Balloon Guide Catheter
K221951 · QJP
Asahi Intecc Co., Ltd.
Neurology · 98d
Cleared Oct 11, 2022
Connected OR Hub with Device and Voice Control, SDC4K Information Management...
K222079 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 88d
Cleared Oct 11, 2022
ECHO Photocoagulator
K222157 · HQF
Norlase
Ophthalmic · 83d
Cleared Oct 11, 2022
Surgical Mask
K222335 · FXX
Luoyang Sunmed Devices Co., Ltd.
General Hospital · 69d
Cleared Oct 11, 2022
IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439
K222432 · OHT
Hunan Guangye Biotechnology Co., Ltd.
General & Plastic Surgery · 60d
Cleared Oct 11, 2022
Renamel® Microhybrid
K222435 · EBF
Cosmedent, Inc.
Dental · 60d
Cleared Oct 11, 2022
Sol-M Luer Lock Syringe
K222744 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 29d
Cleared Oct 08, 2022
Disposable Vinyl Examination Gloves
K223008 · LYZ
Jiangxi Handspro Products Solutions...
General Hospital · 9d
Cleared Oct 07, 2022
Mico One Orthodontic Screw
K202163 · OAT
Ze Fang Technology Co., Ltd.
Dental · 795d
Cleared Oct 07, 2022
SuperCheck Pro Blood Glucose Monitoring System
K213061 · NBW
Ok Biotech Co., Ltd.
Chemistry · 380d