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
1465–1488 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Dec 10, 2021
Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination...
K212349 · LZA
Medi Legion Sdn.Bhd
General Hospital · 135d
Cleared Dec 10, 2021
Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level...
K203539 · FYA
Unicoglobal, Inc.
General Hospital · 372d
Cleared Dec 10, 2021
Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26,...
K201600 · FLL
Kangfu Medical Equipment Factory
General Hospital · 546d
Cleared Dec 09, 2021
Disposable Medical Nitrile Examination Gloves (Model:XYS-001)
K213371 · LZA
Anhui Xinyisheng Medical Technology...
General Hospital · 58d
Cleared Dec 08, 2021
BD Nano 2nd Gen Pen Needle
K213156 · FMI
Becton, Dickinson and Company
General Hospital · 79d
Cleared Dec 08, 2021
Disposable Medical Nitrile Examination Gloves (Non sterile)
K212639 · LZC
Jiangsu Nanfang Medical Co., Ltd.
General Hospital · 110d
Cleared Dec 08, 2021
Infrared forehead thermometer LD-FT-100B
K211629 · FLL
Honsun (Nantong) Co., Ltd.
General Hospital · 195d
Cleared Dec 08, 2021
MAF Guard
K211487 · FXX
Maf Clothing Pvt Ltd Unit-3
General Hospital · 209d
Cleared Dec 07, 2021
Comfortpro
K212438 · LYY
Thai Rubber Industry Company Limited
General Hospital · 125d
Cleared Dec 07, 2021
BAYLAB 3-Ply Surgical Mask (BEACON I)
K212302 · FXX
Baylab USA, LLC
General Hospital · 137d