Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
1801–1824 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 15, 2021
Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K211547 · LZA
Edma Group, LLC
General Hospital · 57d
Cleared Jul 15, 2021
Disposable Procedural Ear-loop Face Mask
K211042 · FXX
Changzhou Dsb Medical Co., Ltd.
General Hospital · 98d
Cleared Jul 15, 2021
Crosstex VH2O2 Chemical Indicators
K200096 · JOJ
Crosstex International, Inc. (A...
General Hospital · 546d
Cleared Jul 14, 2021
Surgical Face Mask, Surgical Mask
K201844 · FXX
Lear Corporation
General Hospital · 373d
Cleared Jul 12, 2021
Nitrile Examination Gloves
K210776 · LZA
5r Med Instruments (Chengdu) Co., Ltd.
General Hospital · 119d
Cleared Jul 12, 2021
Nitrile Patient Examination Glove
K210723 · LZA
Jiangxi Zhonghong Pulin Medical...
General Hospital · 124d
Cleared Jul 12, 2021
Disposable Medical Face Mask
K210244 · FXX
Suzhou Bolisi Medical Technology Co.,...
General Hospital · 164d
Cleared Jul 10, 2021
Medical Nitrile Examination Gloves (Power free, Blue)
K210578 · LZA
Jiangxi Hongda Medical Equipment...
General Hospital · 134d
Cleared Jul 09, 2021
Medical PVC Examination Gloves
K210821 · LYZ
Jiangxi Hongda Medical Equipment...
General Hospital · 112d
Cleared Jul 09, 2021
Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with...
K200915 · KGO
Gx Corporation Sdn Bhd
General Hospital · 459d
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