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
1921–1944 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 25, 2021
BRS Procedure Face Mask
K202824 · FXX
Blackbriar Regulatory Services, LLC
General Hospital · 182d
Cleared Mar 25, 2021
Disposable Medical Mask
K202133 · FXX
Hangzhou Qianzhiya Sanitary Products...
General Hospital · 237d
Cleared Mar 25, 2021
Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with...
K202083 · LZA
Shen Wei (Usa), Inc.
General Hospital · 241d
Cleared Mar 25, 2021
NeedleSmart Professional (NS Pro)
K202073 · MTV
Needlesmart Limited
General Hospital · 241d
Cleared Mar 25, 2021
ST-Z5
K201878 · KCT
Z-Systems AG
General Hospital · 261d
Cleared Mar 24, 2021
STERIZONE VP4 Test Pack
K203560 · FRC
Tso3 Inc., Now A Part of Stryker
General Hospital · 107d
Cleared Mar 24, 2021
Medical disposable face mask non sterile
K202650 · FXX
Guangdong Zhong Ling Industrial Group...
General Hospital · 191d
Cleared Mar 24, 2021
Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis...
K202080 · LZA
Shen Wei (Usa), Inc.
General Hospital · 240d
Cleared Mar 24, 2021
Safety Subcutaneous Infusion Set
K201626 · FPA
Epic Medical Pte. , Ltd.
General Hospital · 281d
Cleared Mar 23, 2021
ICU Health Surgical Mask
K203064 · FXX
Plastikon Industries
General Hospital · 165d
Cleared Mar 22, 2021
EZ-IO Intraosseous Vascular Access System
K202492 · FMI
Teleflex Medical
General Hospital · 203d
Cleared Mar 22, 2021
Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008,...
K202009 · FLL
Shenzhen Juzhong Technology Co., Ltd.
General Hospital · 244d
Cleared Mar 19, 2021
Patient Examination Gloves
K203593 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 100d
Cleared Mar 19, 2021
Disposable Medical Face Mask
K202628 · FXX
Qinghai Zhong Dao Win-Win Medical...
General Hospital · 189d
Cleared Mar 19, 2021
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis...
K202081 · LZA
Shen Wei (Usa), Inc.
General Hospital · 235d
Cleared Mar 19, 2021
Sovereign America Surgical Face Mask
K201095 · FXX
Homtex, Inc.
General Hospital · 329d
Cleared Mar 18, 2021
Spin Care Disposable Protective Mask
K201624 · FXX
Spintech, LLC
General Hospital · 276d
Cleared Mar 17, 2021
Biodegradable Powder Free Nitrile Examination Glove, Green-White and...
K202082 · LZA
Shen Wei (Usa), Inc.
General Hospital · 233d
Cleared Mar 16, 2021
MIPLNI YK-244 Disposable Surgical Mask
K210487 · FXX
Hunan Yuankang Biological Technology...
General Hospital · 25d
Cleared Mar 16, 2021
Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential...
K202086 · LZA
Shen Wei (Usa), Inc.
General Hospital · 232d
Cleared Mar 15, 2021
Single-Use Surgical Mask
K201924 · FXX
Qiqihar Hengxin Medical Supplies, Ltd.
General Hospital · 248d
Cleared Mar 15, 2021
Medical Surgical Mask
K201698 · FXX
Hangzhou Mycode Bio-Medicine Co., Ltd.
General Hospital · 266d
Cleared Mar 12, 2021
AIC disposable medical mask
K203775 · FXX
The Aleen International Corporation
General Hospital · 74d
Cleared Mar 12, 2021
Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603
K203707 · FLL
Shenzhen Zhengkang Technology Co., Ltd.
General Hospital · 84d