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
1441–1464 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 18, 2021
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
K213051 · LZA
Yunnan Huazhiyuan Medical Technology...
General Hospital · 87d
Cleared Dec 18, 2021
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
K213048 · LZA
Huayuan Medical Technology(Shangqiu)...
General Hospital · 87d
Cleared Dec 18, 2021
Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace...
K212932 · KCT
Nobel Biocare Services AG
General Hospital · 94d
Cleared Dec 18, 2021
USA Gloves Nitrile Powder Free Exam Gloves
K211624 · LZA
Usa Gloves
General Hospital · 205d
Cleared Dec 18, 2021
Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)
K211457 · LZA
Ammex Corporation
General Hospital · 221d
Cleared Dec 17, 2021
Surgical Face Mask
K212059 · FXX
Zhongshan Saifute Labor Protective...
General Hospital · 169d
Cleared Dec 17, 2021
Hycare Med+ Nitrile Examination Gloves
K211209 · LZA
Hycare International Co., Ltd.
General Hospital · 238d
Cleared Dec 17, 2021
Sterile Syringe for Single Use
K210914 · FMF
Jiangsu Suyun Medical Material Co., Ltd.
General Hospital · 263d
Cleared Dec 17, 2021
Topwide Surgical Face Mask
K210102 · FXX
Topwide (Hubei) Medical Products...
General Hospital · 337d
Cleared Dec 17, 2021
Donagamex Blue Performance Protective Gown
K203821 · QPC
Dong Nai Garment Corporation (Donagamex)
General Hospital · 353d
Cleared Dec 16, 2021
UltiCare Disposable Pen Needles
K213407 · FMI
Ultimed Incorporated
General Hospital · 58d
Cleared Dec 16, 2021
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For...
K212898 · LZA
Rimba Glove Snd Bhd
General Hospital · 97d
Cleared Dec 16, 2021
AT
K212645 · LZA
At Glove Engineering Sdn. Bhd
General Hospital · 118d
Cleared Dec 16, 2021
LM Surgical Mask Level 3, LM Surgical Mask Level 2,
K211378 · FXX
Liberty Mask, LLC
General Hospital · 226d
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