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
1777–1800 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 08, 2021
Medical surgical mask
K210380 · FXX
Shantou T&K Medical Equipment Factory...
General Hospital · 149d
Cleared Jul 08, 2021
Disposable Surgical Mask
K210267 · FXX
Xiamen Eagledon Pharmaceutical Co., Ltd.
General Hospital · 157d
Cleared Jul 07, 2021
Surgical Mask
K210524 · FXX
Changzhou Holymed Products Co., Ltd.
General Hospital · 134d
Cleared Jul 07, 2021
Surgical Gowns
K210215 · FYA
Jiangsu Province Jianerkang Medical...
General Hospital · 161d
Cleared Jul 07, 2021
Infrared Forehead Thermometer
K202741 · FLL
Shenzhen Combei Technology Co., Ltd.
General Hospital · 292d
Cleared Jul 06, 2021
KARL STORZ Metal Sterilization Trays
K203198 · KCT
KARL STORZ Endoscopy-America, Inc.
General Hospital · 250d
Cleared Jul 02, 2021
Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3...
K211422 · FYA
Jiangsu Medplus Non-Woven...
General Hospital · 56d
Cleared Jul 02, 2021
Single-use Medical Face Mask
K203591 · FXX
Conod Medical Co., Limited
General Hospital · 206d
Cleared Jul 02, 2021
Disposable Surgical Mask
K202954 · FXX
Xiamen Probtain Medical Techology...
General Hospital · 275d
Cleared Jul 02, 2021
Insulin Syringe, Insulin Syringe with Safety Retractable
K202570 · MEG
Jiangsu Micsafe Medical Technology...
General Hospital · 301d
Cleared Jul 01, 2021
EZ-TRAXTM Persona Knee Containment Device
K211007 · KCT
K1 Medical, LLC
General Hospital · 90d
Cleared Jul 01, 2021
Bravo G4 Chamber Autoclave
K210326 · FLE
Scican , Ltd.
General Hospital · 147d
Cleared Jun 29, 2021
Nordiwell Surprotect Face Mask
K210445 · FXX
Changzhou Combat Protective Equipment...
General Hospital · 133d
Cleared Jun 28, 2021
White Nitrile Powder Free Patient Examination Glove, Non Sterile
K210775 · LZA
Onetexx Sdn Bhd
General Hospital · 105d
Cleared Jun 28, 2021
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
K210587 · LZA
Onetexx Sdn Bhd
General Hospital · 122d
Cleared Jun 25, 2021
Safety Winged Blood Collection Sets
K211293 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 60d
Cleared Jun 25, 2021
Nitrile Glove
K211252 · LZA
Jiangsu Dihong Industry and Trade...
General Hospital · 60d
Cleared Jun 24, 2021
SMARTRELEASE Endoscopic Soft Tissue Release System
K211297 · HRX
Microaire Surgical Instruments
General Hospital · 57d
Cleared Jun 24, 2021
ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content...
K210656 · KGO
Careplus (M) Sdn Bhd
General Hospital · 112d
Cleared Jun 24, 2021
Powder Free Black Nitrile Examination Glove
K201428 · LZA
Vietglove Corporation
General Hospital · 391d
Cleared Jun 23, 2021
Synthetic Vinyl Examination Gloves
K211045 · LYZ
Jiangsu Huayuan Medical Technology...
General Hospital · 76d
Cleared Jun 23, 2021
NovoFine
K210258 · FMI
Novo Nordisk, Inc.
General Hospital · 142d
Cleared Jun 22, 2021
Disposable Surgical Mask
K210840 · FXX
Safeway Industry Healthcare.
General Hospital · 92d
Cleared Jun 21, 2021
Steri-Dot Process Indicator
K210866 · JOJ
Propper Manufacturing Co., Inc.
General Hospital · 90d