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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13849–13872 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 2022
Wearable Breast Pump (Model S12)
K212180 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 214d
Cleared Feb 11, 2022
FlexitSystem Knee osteotomy system
K212545 · HRS
Neosteo
Orthopedic · 183d
Cleared Feb 11, 2022
OsteoPlan System
K212570 · DZJ
Osteomed, LLC
Dental · 179d
Cleared Feb 11, 2022
Zyter RPM
K212622 · MSX
Zyter, Inc.
Cardiovascular · 177d
Cleared Feb 11, 2022
Actively Trying Personal Lubricant Rose Scented
K212885 · PEB
CC Wellness, LLC
Obstetrics & Gynecology · 154d
Cleared Feb 11, 2022
Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
K213328 · HSB
Stryker GmbH
Orthopedic · 129d
Cleared Feb 11, 2022
EzRay M18 (Model: VMX-P400)
K213462 · IZL
VATECH Co., Ltd.
Radiology · 107d
Cleared Feb 11, 2022
ACUSON P500 Ultrasound System
K213487 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 105d
Cleared Feb 11, 2022
SIGNA Artist Evo
K213603 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 88d
Cleared Feb 11, 2022
Surgical Face Mask
K213617 · FXX
Megasoft (China) Co., Ltd.
General Hospital · 88d
Cleared Feb 11, 2022
B. Braun Introcan Safety 2 IV Catheter
K213664 · FOZ
B.Braun Medical, Inc.
General Hospital · 81d
Cleared Feb 11, 2022
MAVERICK External Fixation System
K213874 · JDW
Smith & Nephew, Inc.
Orthopedic · 60d
Cleared Feb 11, 2022
IMICRYL Impression Materials
K213890 · ELW
Imicryl Dis Malzemeleri San. VE Tic....
Dental · 60d
Cleared Feb 10, 2022
NervAlign Nerve Cuff
K202234 · JXI
Renerve, Ltd.
Neurology · 552d
Cleared Feb 10, 2022
Action Trackchair Hawk
K202728 · IPL
Action Manufacturing, Inc.
Physical Medicine · 510d
Cleared Feb 10, 2022
Micro Catheter
K202926 · QJP
Shanghai Heartcare Medical Technology...
Neurology · 499d
Cleared Feb 10, 2022
GPC Intraheal Intramedullary Nailing System
K203811 · HSB
Gpc Medical Limited
Orthopedic · 409d
Cleared Feb 10, 2022
Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed...
K211327 · DRF
CathRx, Ltd.
Cardiovascular · 283d
Cleared Feb 10, 2022
Zeolite Hemostatic Gauze
K211570 · QSY
Hangzhou Zeo-Innov Life Technology...
General & Plastic Surgery · 265d
Cleared Feb 10, 2022
NPseal
K212971 · OKO
Guard Medical, Inc.
General & Plastic Surgery · 146d
Cleared Feb 10, 2022
Instylla Delivery Kit
K213632 · FMF
Instylla, Inc.
General Hospital · 85d
Cleared Feb 10, 2022
Pure-Vu EVS System
K220007 · FDF
Motus GI Medical Technologies , Ltd.
Gastroenterology & Urology · 37d
Cleared Feb 09, 2022
Infrascanner
K211617 · OPT
Infrascan, Inc.
Neurology · 259d
Cleared Feb 09, 2022
R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire,...
K212167 · DQX
Vascular Solutions, LLC
Cardiovascular · 212d