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
553–576 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 26, 2024
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential...
K233560 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 112d
Cleared Feb 16, 2024
SCIg60 Infusion System
K240148 · PKP
Emed Technologies Corporation
General Hospital · 28d
Cleared Feb 16, 2024
Airgle Room Air Purifier
K232645 · FRA
Airgle Corporation
General Hospital · 170d
Cleared Feb 16, 2024
Medline Luer Lock Syringes
K230235 · FMF
Medline Industries, LP
General Hospital · 385d
Cleared Feb 15, 2024
Breathing circuit bacterial/viral filter
K222917 · CAH
Shaoxing Haitech Medical Products...
General Hospital · 507d
Cleared Feb 13, 2024
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K233740 · LZA
W.A. Rubbermate Co., Ltd.
General Hospital · 83d
Cleared Feb 09, 2024
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use...
K240072 · LZA
Luliang Hongruida Health Protection...
General Hospital · 30d
Cleared Feb 09, 2024
Infrared Thermometer: Model YJ600
K232473 · FLL
Zhuhai Yueja Medical Device...
General Hospital · 177d
Cleared Feb 08, 2024
Lexa MINI (RIS-303, RIS-305)
K233504 · FLE
W&H Sterilization S.R.L.
General Hospital · 100d
Cleared Feb 07, 2024
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with...
K232764 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 152d
Cleared Feb 01, 2024
Surgical Gown (40083)
K233183 · FYA
Ammex-Weida (Hubei) Health and Safety...
General Hospital · 126d
Cleared Feb 01, 2024
Sterile Safety Hypodermic Needles for Single Use
K232165 · FMI
Berpu Medical Technology Co., Ltd.
General Hospital · 195d
Cleared Jan 31, 2024
Digital Thermometer, Model T28, T28L
K232678 · FLL
Guangdong Genial Technology Co., Ltd.
General Hospital · 152d
Cleared Jan 26, 2024
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested...
K233598 · LZA
Anhui Intco Medical Products Co., Ltd.
General Hospital · 78d
Cleared Jan 26, 2024
LifeOutcomes C-Quest™ Blood Culture Sampling Device
K231282 · JKA
Lifeoutcomes, LLC
General Hospital · 268d
Cleared Jan 19, 2024
Mix2Vial® Transfer Device
K231071 · LHI
West Pharma Services Il, Ltd.
General Hospital · 280d
Cleared Jan 16, 2024
Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use...
K233970 · LZA
Nephron Nitrile, LLC
General Hospital · 32d
Cleared Jan 16, 2024
Washtrays
K231144 · KCT
Dentsply Sirona
General Hospital · 270d
Cleared Jan 12, 2024
Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use...
K233520 · LZA
Anhui Powerguard Technology Co., Ltd.
General Hospital · 72d
Cleared Jan 12, 2024
Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask...
K233022 · MSH
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 112d
Cleared Jan 12, 2024
SoloSmart Injection Pen Adapter (SoloSmart®)
K231820 · QOG
Biocorp Production
General Hospital · 205d
Cleared Jan 12, 2024
SMB Luer lock disposable syringe
K231558 · FMF
Smb Corporation of India
General Hospital · 227d
Cleared Jan 11, 2024
ToxiSeal Vial Adapter with External Balloon
K222929 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 472d
Cleared Jan 08, 2024
HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT*...
K232894 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 112d