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
1945–1968 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 31, 2021
Digital Thermometer Model T103, T104
K201879 · FLL
Bioland Technology, Ltd.
General Hospital · 267d
Cleared Mar 30, 2021
Blue Nitrile Exam Glove, Powder Free
K210058 · LZA
Great Harvest Trading Co., Ltd.
General Hospital · 78d
Cleared Mar 30, 2021
Surgical Face Masks
K202708 · FXX
Intco Medical(Hk) Co., Ltd.
General Hospital · 195d
Cleared Mar 30, 2021
ivi N3003 Surgical face Mask, ivi N6006 Surgical mask
K201896 · FXX
Iob Medical, Inc.
General Hospital · 265d
Cleared Mar 29, 2021
Surgical Mask
K202191 · FXX
Wuhan Zonsen Medical Products Co., Ltd.
General Hospital · 236d
Cleared Mar 26, 2021
Disposable Surgical Face Mask
K203685 · FXX
Xiantao Zhongyi Safety & Protection...
General Hospital · 99d
Cleared Mar 26, 2021
Disposable Face Mask
K202905 · FXX
Jiangsu Excellence Medical Supplies...
General Hospital · 178d
Cleared Mar 26, 2021
RG 3ml Medication Cartridge
K201634 · MRZ
Chengdu Shifeng Medical Technology...
General Hospital · 283d
Cleared Mar 25, 2021
Surgical Masks, Model SNN200640 & MN112
K203776 · FXX
Sq Medical Supplies, Inc.
General Hospital · 87d
Cleared Mar 25, 2021
NEBULAE SRS Laparoscopic Surgical Smoke Removal System
K202944 · FYD
Northgate Technologies, Inc.
General Hospital · 176d
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