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
1201–1224 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 26, 2022
Disposable Surgical Face Mask (FM-34EE,FM-44EE)
K220597 · FXX
Qingdao Bestex Rubber & Plastic...
General Hospital · 86d
Cleared May 26, 2022
Powder Free Nitrile Examination Gloves, Blue, Tested for use with...
K220545 · LZC
Hl Rubber Industries Sdn Bhd
General Hospital · 90d
Cleared May 26, 2022
Sterile Nitrile Powder Free Examination Gloves Tested For Use With...
K220249 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 115d
Cleared May 26, 2022
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram...
K214074 · KGO
Hartalega NGC Sdn. Bhd.
General Hospital · 150d
Cleared May 26, 2022
Aura Storm
K212644 · FRA
Invictus Lighting
General Hospital · 279d
Cleared May 26, 2022
PP Care Nitrile Examination Gloves
K212629 · LZA
Eg Group Product and Services Co., Ltd.
General Hospital · 280d
Cleared May 25, 2022
LDV((Low Dead Volume )Syringe
K220083 · QNQ
Anhui Hongyu Wuzhou Medical...
General Hospital · 135d
Cleared May 25, 2022
Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E
K213485 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 208d
Cleared May 25, 2022
Disposable Sterilized Latex Surgical Gloves
K211953 · KGO
Jiangxi Kemei Medical Apparatus &...
General Hospital · 336d
Cleared May 25, 2022
Well-life TM Pen Needles, Well-life TM Safety Pen Needles
K210748 · FMI
W. L. Med Co., Ltd.
General Hospital · 439d
Cleared May 24, 2022
Disposable Face Mask
K220191 · FXX
Jiujiang Taixin Technology Co., Ltd.
General Hospital · 120d
Cleared May 24, 2022
S-Line
K213191 · LGZ
Barkey GmbH & Co. KG
General Hospital · 237d
Cleared May 23, 2022
3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam...
K220564 · JOJ
3M Company
General Hospital · 84d
Cleared May 23, 2022
Disposable surgical mask
K220532 · FXX
Xiamen Blue Star Enterprise Co., Ltd.
General Hospital · 88d
Cleared May 23, 2022
3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large
K220507 · PZW
3M Company
General Hospital · 90d
Cleared May 23, 2022
Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
K220155 · LZA
Motex Healthcare (Anhui) Co., Ltd.
General Hospital · 124d
Cleared May 23, 2022
Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with...
K211810 · LZA
Pt. Shamrock Manufacturing Corpora
General Hospital · 346d
Cleared May 19, 2022
Procedure Mask with Ear Loops and Surgical Mask with Ties
K221134 · FXX
Safesource Direct, LLC
General Hospital · 30d
Cleared May 19, 2022
Medical Surgical Mask (Planar type)
K220824 · FXX
Hunan Chopard Medical Devices Co., Ltd.
General Hospital · 59d
Cleared May 18, 2022
Medline Orbis LVL 3 Surgical Gown
K220333 · FYA
Medline Industries, LP
General Hospital · 103d
Cleared May 18, 2022
Nitrile Powder Free Examination Gloves
K220211 · LZA
Hebei Kangxida Medical Technology...
General Hospital · 112d
Cleared May 18, 2022
GSS610N21 Series Steam Sterilizer
K214120 · FLE
Maquet GmbH
General Hospital · 139d
Cleared May 18, 2022
Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy...
K212408 · LZA
Pt. Maja Agung Latexindo
General Hospital · 288d
Cleared May 17, 2022
Procedure mask/Surgical mask/Face mask
K220194 · FXX
Winner Medical Co., Ltd.
General Hospital · 113d