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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
2041–2064 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 06, 2021
Medical Surgical Gowns
K202844 · FYA
Beijing Biosis Healing Biolog Ical...
General Hospital · 103d
Cleared Jan 06, 2021
Medical Surgical Masks-Non Sterile
K202594 · FXX
Shandong T&F Nonwoven Co., Ltd.
General Hospital · 120d
Cleared Jan 06, 2021
Disposable Surgical Face Mask
K202491 · FXX
Jiangsu Newvalue Medical Products...
General Hospital · 128d
Cleared Jan 05, 2021
iHealth Clinical Digital Thermometer
K202791 · FLL
Andon Health Co, Ltd.
General Hospital · 105d
Cleared Jan 05, 2021
NeutrArt
K201872 · FPA
Asset Medikal Tasarim As.
General Hospital · 182d
Cleared Jan 05, 2021
Non-contact Infrared Body Thermometer, model:HTD8823US
K200159 · FLL
Hetaida Technology Co., Ltd.
General Hospital · 349d
Cleared Jan 05, 2021
Insulin Syringe
K193273 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 406d
Cleared Jan 04, 2021
Disposable Medical Face Masks
K202719 · FXX
Jiangxi Sanxin Medtec Co., Ltd.
General Hospital · 109d
Cleared Dec 31, 2020
Surgical Gown (Sterile), Surgical Gown (Non-sterile)
K202706 · FYA
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT...
General Hospital · 106d
Cleared Dec 31, 2020
Promisemed Covered Safety Pen Needle
K202681 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 107d
Cleared Dec 31, 2020
Nordiwell Medical Face Mask
K202615 · FXX
Changzhou Combat Protective Equipment...
General Hospital · 113d
Cleared Dec 30, 2020
Remunity Pump for Remodulin (treprostinil) Injection
K202690 · QJY
Deka Research and Development
General Hospital · 106d
Cleared Dec 30, 2020
CrossRoads Tray System
K202268 · KCT
Crossroads Extremity Systems, LLC
General Hospital · 141d
Cleared Dec 30, 2020
JianYu Surgical Mask
K201754 · FXX
Jiangsu Jianyu Health Medical Co., Ltd.
General Hospital · 184d
Cleared Dec 28, 2020
Self-Contained Biological Indicator
K200970 · FRC
True Indicating, LLC
General Hospital · 259d
Cleared Dec 28, 2020
Novaerus NV1050
K200321 · FRF
Novaerus Us, Inc.
General Hospital · 322d
Cleared Dec 23, 2020
Medical Face mask
K202061 · FXX
Jiangsu Province Jianerkang Medical...
General Hospital · 149d
Cleared Dec 23, 2020
DeRoyal Temperature Monitoring Probe
K200631 · FLL
Deroyal Industries, Inc.
General Hospital · 288d
Cleared Dec 22, 2020
Disposable Medical Surgical Face Masks
K202211 · FXX
Guangdong Kaidi Garments Co.,Ltd
General Hospital · 138d
Cleared Dec 19, 2020
Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove,...
K202668 · KGO
Medline Industries, Inc.
General Hospital · 96d
Cleared Dec 19, 2020
NovoFine Plus 32G Tip x 4 mm
K202005 · FMI
Novo Nordisk, Inc.
General Hospital · 151d
Cleared Dec 18, 2020
Infrared Thermometer
K201980 · FLL
Contec Medical Systems Co.,Ltd
General Hospital · 155d
Cleared Dec 18, 2020
BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV...
K201075 · FOZ
Becton, Dickinson and Company
General Hospital · 240d
Cleared Dec 18, 2020
Fever Garde
K191978 · FLL
Hubdic Co., Ltd.
General Hospital · 513d