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
1609–1632 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 24, 2021
Disposable Medical Surgical Mask
K210348 · FXX
Weihai Dishang Medical Technology...
General Hospital · 258d
Cleared Oct 22, 2021
UroLift System Rigid Retrieval Kit Sterilization Tray
K212396 · KCT
Neotract, Inc.
General Hospital · 81d
Cleared Oct 22, 2021
STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
K212200 · MLR
Plasmapp Co,., Ltd.
General Hospital · 100d
Cleared Oct 22, 2021
Tyvek(R) Roll with CI for STERLINKTM Sterilizer
K212198 · FRG
Plasmapp Co,., Ltd.
General Hospital · 100d
Cleared Oct 22, 2021
Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators...
K212193 · FRC
Plasmapp Co,., Ltd.
General Hospital · 100d
Cleared Oct 21, 2021
Medical Examination Gloves
K212311 · LZA
Guangzhou Junda Gloves Co., Ltd.
General Hospital · 90d
Cleared Oct 19, 2021
Sterile High-pressure Angiographic Syringes for Single-use
K211564 · DXT
Shenzhen Boon Medical Supply Co., Ltd.
General Hospital · 152d
Cleared Oct 19, 2021
Nitrile Examination Gloves
K210706 · LZA
Niujian Technology Co., Ltd.
General Hospital · 223d
Cleared Oct 19, 2021
Surgical 3D Mask
K203565 · FXX
Inno Lifecare
General Hospital · 316d
Cleared Oct 18, 2021
Surgical Gown
K211809 · FYA
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 129d
Cleared Oct 18, 2021
Hypodermic Safety Needle
K211555 · MEG
Anhui Hongyu Wuzhou Medical...
General Hospital · 152d
Cleared Oct 14, 2021
Medical Protective Masks
K212205 · FXX
Qinhuangdao Taizhi Medical Technology...
General Hospital · 91d
Cleared Oct 14, 2021
Nitrile Patient Examination Gloves
K211914 · LZA
Yingxiang Glove Products Co., Ltd.
General Hospital · 115d
Cleared Oct 14, 2021
Sterile Syringe With Safety Needle
K211753 · MEG
Jiangxi Hongda Medical Equipment...
General Hospital · 129d
Cleared Oct 14, 2021
Sterile Hypodermic Needles for Single Use
K211214 · FMI
Azur Medical Company, Inc.
General Hospital · 174d
Cleared Oct 14, 2021
Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special...
K211121 · PTI
Intera Oncology, Inc.
General Hospital · 182d
Cleared Oct 13, 2021
MiniLoad Syringe
K212544 · FMF
Ocuject, LLC
General Hospital · 62d
Cleared Oct 13, 2021
Medical Nitrile Examination Gloves
K212014 · LZA
Jiangxi Ronglai Medical Technology...
General Hospital · 107d
Cleared Oct 13, 2021
Proclean - Nitrile Powder Free Examination Gloves
K211374 · LZA
Dr.Boo Company Limited
General Hospital · 162d
Cleared Oct 12, 2021
Nitrile examination gloves
K211927 · LZA
Fitone Latex Products Co., Ltd....
General Hospital · 112d
Cleared Oct 12, 2021
Disposable Surgical Mask (Model: YYKZ-01)
K210845 · FXX
Jiaxing Amazing Travel-Ware Co., Ltd.
General Hospital · 204d
Cleared Oct 10, 2021
Child Face Mask
K201514 · OXZ
Shandong Shengquan New Material Co.,...
General Hospital · 489d
Cleared Oct 09, 2021
STERRAD 100NX Sterilizer with ALLClear Technology
K212174 · MLR
Advanced Sterilization Products, Inc.
General Hospital · 89d
Cleared Oct 08, 2021
Medical Examination Gloves
K212078 · LZA
Guangdong Gymda Medical Technology...
General Hospital · 98d