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
841–864 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 13, 2023
Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested...
K223859 · LZA
Rhino Health, Inc.
General Hospital · 52d
Cleared Feb 13, 2023
Sterilization Pouch and Roll
K221875 · FRG
Qianjiang Kingphar Medical Packaging...
General Hospital · 230d
Cleared Feb 13, 2023
Sofjec
K212635 · FMF
Hwajin Medical Co., Ltd.
General Hospital · 543d
Cleared Feb 10, 2023
Disposable Isolation Gown
K223467 · FYC
Nanning Tecbod Biological Technology...
General Hospital · 85d
Cleared Feb 10, 2023
Nitrile Examination Powder Free Glove, Blue Tested For Use With 32...
K222129 · LZA
Top Glove Medical (Thailand) Co., Ltd.
General Hospital · 207d
Cleared Feb 10, 2023
PRIMUS Healthcare Sterilizer (Model PSS11-HC)
K221474 · FLE
Primus Sterilizer Company, LLC
General Hospital · 266d
Cleared Feb 10, 2023
Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)
K220657 · FLL
Zhejiang Rongsheng Industrial Co., Ltd.
General Hospital · 340d
Cleared Feb 10, 2023
SEJONG Surgical Gown Soft
K220435 · FYA
Sejong Healthcare Co., Ltd.
General Hospital · 361d
Cleared Feb 09, 2023
Sterile Syringes for Single Use
K223678 · FMF
Shanghai Kindly Enterprise...
General Hospital · 63d
Cleared Feb 09, 2023
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With...
K223559 · LZA
Nephron Pharmaceuticals Corporation
General Hospital · 73d
Cleared Feb 09, 2023
Insulin syringe with integrated needle DL
K203211 · FMF
Dlp Medical Products, Corp.
General Hospital · 832d
Cleared Feb 08, 2023
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
K223304 · FYC
Xiamen Probtain Medical Technology...
General Hospital · 104d
Cleared Feb 08, 2023
Filter and HME/Filter
K221472 · CAH
Ningbo Huakun Medical Equipment Co.,...
General Hospital · 264d
Cleared Feb 07, 2023
Medical Protective Masks
K223686 · FXX
Qinhuangdao Taizhi Medical Technology...
General Hospital · 60d
Cleared Feb 06, 2023
Powder Free Blue Nitrile Examination Glove
K223444 · LZA
S&S Glove Corporation
General Hospital · 84d
Cleared Feb 06, 2023
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
K221980 · LYZ
Ever Global (Vietnam) Enterprise...
General Hospital · 216d
Cleared Feb 03, 2023
Cook® Spectrum® 2 MRC Central Venous Catheter
K223648 · FOZ
Cook Advanced Technologies
General Hospital · 59d
Cleared Feb 02, 2023
SmartRelease Endoscopic Soft Tissue Release System
K223406 · HRX
Microaire Surgical Instruments
General Hospital · 85d
Cleared Feb 02, 2023
Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869
K213545 · FLE
Steelco S.P.A.
General Hospital · 451d
Cleared Jan 27, 2023
Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use...
K223903 · LZA
Semperit Investments Asia Pte , Ltd.
General Hospital · 30d
Cleared Jan 26, 2023
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for...
K223415 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 77d
Cleared Jan 26, 2023
Surgical Gown
K222403 · FYA
Guangzhou Fuzelong Hygiene Material...
General Hospital · 170d
Cleared Jan 26, 2023
Sterile Surgical Powder Free Latex Glove
K221424 · KGO
New Era Medicare Sdn. Bhd.
General Hospital · 255d
Cleared Jan 25, 2023
PowerPAK Syringe
K220114 · MEG
Vault Paragon Group, Inc.
General Hospital · 376d