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
1873–1896 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 27, 2021
ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content...
K202765 · KGO
Careplus (M) Sdn Bhd
General Hospital · 248d
Not Cleared May 27, 2021
SafeBreak Vascular
DEN190043 · QOI
Site Saver, Inc. D/B/A Lineus Medical
General Hospital · 617d
Cleared May 26, 2021
Disposable Synthetic Examination Gloves
K210520 · LYZ
Shandong Shengshixincheng Medical...
General Hospital · 92d
Cleared May 25, 2021
AirMax Procedure Mask
K211275 · FXX
Premiumestore, LLC
General Hospital · 28d
Cleared May 20, 2021
YUWELL infrared ear thermometer: YHT101, YHT200
K203583 · FLL
Jiangsu Yuyue Medical Equipment&...
General Hospital · 163d
Cleared May 20, 2021
Surgical Isolation Gown
K203415 · FYC
Yanbian Pacific Textile Co., Ltd.
General Hospital · 182d
Cleared May 20, 2021
Procedure Mask, Surgical Mask
K202899 · FXX
Kenpax International Limited
General Hospital · 233d
Cleared May 19, 2021
Steam-Dot Process Indicator
K210553 · JOJ
Propper Manufacturing Co., Inc.
General Hospital · 83d
Cleared May 19, 2021
Turbett Instrument Pod
K202593 · FRG
Turbett Surgical, Inc.
General Hospital · 253d
Cleared May 19, 2021
Disposable Latex Powder Free Examination Gloves (Non-sterile)
K201576 · LYY
Pt. Universal Gloves
General Hospital · 342d
Cleared May 17, 2021
Ear-Friendly Mask
K211105 · FXX
Ray Co., Ltd.
General Hospital · 34d
Cleared May 17, 2021
NitriTec Vinyl Glove Powder Free Blue
K210460 · LYZ
Zhonghong Pulin Medical Products Co.,...
General Hospital · 90d
Cleared May 17, 2021
Needleless Connector
K210217 · FPA
Jiangsu Caina Medical Co.,Ltd
General Hospital · 110d
Cleared May 14, 2021
Powder Free Vinyl Patient Examination Gloves
K210799 · LYZ
Yunnan Huazhiyuan Medical Technology...
General Hospital · 59d
Cleared May 14, 2021
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K210780 · LYZ
Shandong Shangwei Medical Products...
General Hospital · 60d
Cleared May 14, 2021
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K210774 · LYZ
Shandong Jieshi Medical Products Co.,...
General Hospital · 60d
Cleared May 14, 2021
Disposable Medical mask
K210302 · FXX
Anhui Jbh Medical Apparatus Co., Ltd.
General Hospital · 100d
Cleared May 14, 2021
1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle....
K210200 · FMF
Set Medikal Sanayi VE Ticaret Anonim...
General Hospital · 109d
Cleared May 13, 2021
Disposable Face Mask
K210815 · FXX
Biobase Scientific (Shandong) Co., Ltd.
General Hospital · 56d
Cleared May 13, 2021
Powder Free Nitrile Examination Glove
K210369 · LZA
Pastel Glove Sdn Bhd
General Hospital · 94d
Cleared May 13, 2021
United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High...
K202697 · FXX
United Sewing Automation, Inc.
General Hospital · 239d
Cleared May 12, 2021
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid...
K210737 · MED
STERIS Corporation
General Hospital · 62d
Cleared May 10, 2021
Single-use medical poly (vinyl chloride) examination glove
K201504 · LYZ
Anhui Bytech Medical Supplies Co., Ltd.
General Hospital · 339d
Cleared May 07, 2021
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
K210755 · LZA
Meditech Gloves Sdn Bhd
General Hospital · 53d