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
1489–1512 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 16, 2021
Surgical Gown, Model: surgical gown-hp-3
K210355 · FYA
Weihai Dishang Medical Technology...
General Hospital · 311d
Cleared Dec 15, 2021
Disposable Surgical Mask
K212944 · FXX
Heilongjiang Yinjia Medical Equipment...
General Hospital · 93d
Cleared Dec 15, 2021
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K212919 · LZA
Jiujiang Taixin Technology Co., Ltd.
General Hospital · 92d
Cleared Dec 15, 2021
Surgical Gown, Reinforced Surgical Gown
K212861 · FYA
Wuhan Zonsen Medical Products Co., Ltd.
General Hospital · 98d
Cleared Dec 15, 2021
Surgical Face Mask (Non-sterile)
K212398 · FXX
Hubei Kimsoul Industrial Co., Ltd.
General Hospital · 135d
Cleared Dec 15, 2021
ProTEC-USA EZDoff Gown
K210405 · QPC
Cadillac Products, Inc.
General Hospital · 308d
Cleared Dec 15, 2021
FREEDOM Integrated Syringe Infusion System
K200176 · FRN
Repro-Med Systems, Inc. Dba Koru...
General Hospital · 691d
Cleared Dec 14, 2021
Nitrile Examination Gloves (Powder free, Blue)
K213029 · LZA
Weihai Hongyu Nonwoven Fabric...
General Hospital · 84d
Cleared Dec 14, 2021
Surgical Face Mask
K212574 · FXX
Xiantao Deming Healthcare Products...
General Hospital · 120d
Cleared Dec 14, 2021
Surgical Mask
K210744 · FXX
Chongqing PA Xijia Biotechnology Co.,...
General Hospital · 277d
Cleared Dec 14, 2021
Blood Collection Needles
K200932 · FMI
Vacutest Kima Srl
General Hospital · 616d
Cleared Dec 13, 2021
Disposable Nitrile Powder-Free Examination Gloves
K213176 · LZA
Anhui Zhong Lian Latex Gloves...
General Hospital · 76d
Cleared Dec 13, 2021
Disposable Surgical Gown
K212925 · FYA
Henan Robestain Medical Products Co.,...
General Hospital · 90d
Cleared Dec 13, 2021
Nitrile Examination Gloves
K212924 · LZA
Shanxi Nacosa Medical Technology Co.,Ltd
General Hospital · 90d
Cleared Dec 13, 2021
Disposable Surgical Gown, Disposable Reinforced Surgical Gown
K212869 · FYA
Fugou County Shenxiang Manufacturing...
General Hospital · 95d
Cleared Dec 13, 2021
Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color
K210388 · LZA
Mexpo International, Inc.
General Hospital · 307d
Cleared Dec 13, 2021
Surgical face mask: F-Y1-A
K202794 · FXX
Jiande Chaomei Daily Chemicals Co., Ltd.
General Hospital · 446d
Cleared Dec 11, 2021
Disposable Vinyl/Nitrile Blend Medical Examination Gloves
K212899 · LYZ
Bytech Dongtai Co., Ltd.
General Hospital · 89d
Cleared Dec 11, 2021
Medical Surgical Mask
K212867 · FXX
Nanchang Kanghua Health Materials...
General Hospital · 94d
Cleared Dec 11, 2021
Nitrile Gloves (Model: NE01)
K212840 · LZA
Byd Auto Industry Company Limited
General Hospital · 95d
Cleared Dec 11, 2021
Iconic Nitrile Glove
K212182 · LZA
Iconic Medicare Sdn Bhd
General Hospital · 151d
Cleared Dec 11, 2021
Siam NTD+ Nitrile Powder-Free Examination gloves
K212085 · LZA
Siam Ntd Corporation Co., Ltd.
General Hospital · 162d
Cleared Dec 10, 2021
Nitrile Examination Gloves
K212922 · LZA
Hsk Medical Apparatus Foshan China...
General Hospital · 87d
Cleared Dec 10, 2021
ComfortPro Blue Nitrile Examination Gloves Powder Free
K212850 · LZA
Thai Rubber Industry Company Limited
General Hospital · 94d