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
889–912 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Jan 22, 2023
Synthetic Polymer Glove - Polyethylene (Black)
K222531 · LZA
Ur Industry Sdn Bhd
General Hospital · 153d
Cleared Jan 20, 2023
FlowArt® Needle-Free Split Septum Valve
K222889 · FPA
Asset Medikal Tasarim San Tic As.
General Hospital · 119d
Cleared Jan 20, 2023
Digital Thermometer, Model: DT007, DT008
K214077 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 389d
Cleared Jan 20, 2023
Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
K203792 · FMI
Pikdare Spa
General Hospital · 753d
Cleared Jan 19, 2023
Disposable Nitrile Examination Glove
K223250 · LZA
Yangzhou Saraguard Medical Supplies...
General Hospital · 90d
Cleared Jan 13, 2023
Nitrile Exam Gloves (Chemotherapy Drug Tested)
K223748 · LZA
Us Medical Glove Company, LLC
General Hospital · 30d
Cleared Jan 13, 2023
Non-Sterile Powder Free Nitrile Examination Gloves
K223221 · LZA
Dynacare Sdn Bhd
General Hospital · 88d
Cleared Jan 13, 2023
Ideal Med Pro 3-Ply Disposable Face Mask
K221682 · FXX
Jsn Holdings, LLC
General Hospital · 217d
Cleared Jan 11, 2023
Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl...
K222181 · LZA
Iconic Medicare Sdn Bhd
General Hospital · 173d
Cleared Jan 06, 2023
Disposable Surgical Face Mask
K203380 · FXX
Shandong Pop Jeans Intelligent...
General Hospital · 780d
Cleared Jan 05, 2023
Safety Push Button Blood Collection Set
K222834 · JKA
Jiangsu Caina Medical Co.,Ltd
General Hospital · 107d
Cleared Jan 04, 2023
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
K223411 · FYC
Xiamen Probtain Medical Techology...
General Hospital · 56d
Cleared Jan 04, 2023
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K222907 · LZA
Rmkh Glove (Cambodia) Co., Ltd.
General Hospital · 100d
Cleared Jan 04, 2023
Surgical Face Mask
K222483 · FXX
Hubei Woozon Healthcare Co., Ltd.
General Hospital · 140d