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
1033–1056 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 06, 2022
Gemini Sterilization Wrap
K220365 · FRG
Medline Industries, LP
General Hospital · 240d
Cleared Oct 04, 2022
Sterile Safety Hypodermic Needles for Single Use
K221080 · FMI
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 04, 2022
Sterile Hypodermic Syringes for Single Use
K221079 · FMF
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 04, 2022
Sterile Hypodermic Syringes for Single Use with Safety Needles
K221073 · MEG
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 04, 2022
Sterile Hypodermic Syringes for Single Use with Needles
K221068 · FMF
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 04, 2022
Sterile Hypodermic Needles for Single Use
K221066 · FMI
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 03, 2022
PCA Syringe Sets
K212262 · FPA
Baxter Healthcare Corporation
General Hospital · 440d
Cleared Oct 03, 2022
Velano Vascular Blood Collection Adapter 
K201237 · JKA
Velano Vascular
General Hospital · 879d
Cleared Oct 01, 2022
Disposable Nitrile Examination Glove
K222937 · LZA
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 5d
Cleared Sep 30, 2022
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization...
K222849 · NVE
Steris
General Hospital · 9d
Cleared Sep 30, 2022
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile
K221378 · LZA
Tec Gloves Industry (M) Sdn.Bhd.
General Hospital · 141d
Cleared Sep 29, 2022
S.I.N. Instrument Kits
K222005 · KCT
S.I.N. ? Sistema DE Implante Nacional...
General Hospital · 84d
Cleared Sep 29, 2022
Surgical Gown (Sterile)
K221637 · FYA
Allmed Medical (Hubei) Protective...
General Hospital · 115d
Cleared Sep 28, 2022
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid...
K222615 · MED
STERIS Corporation
General Hospital · 29d
Cleared Sep 28, 2022
DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
K222442 · LYZ
Anhui Bytech Medical Supplies Co., Ltd.
General Hospital · 47d
Cleared Sep 28, 2022
SteriCUBE® Multiple Tray Sterilization Systems
K222328 · KCT
Stericube, LLC
General Hospital · 57d
Cleared Sep 27, 2022
Infrared thermometer
K221211 · FLL
Shenzhen Yolanda Technology Co., Ltd.
General Hospital · 153d
Cleared Sep 26, 2022
Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
K222266 · FXX
Jingzhou Haixin Green Cross Medical...
General Hospital · 60d
Cleared Sep 26, 2022
Flowart
K221473 · FPA
Asset Medikal Tasarim As.
General Hospital · 129d
Cleared Sep 24, 2022
Single-use medical latex examination gloves (LG100)
K222693 · LYY
Fitone Latex Products Co., Ltd....
General Hospital · 18d
Cleared Sep 24, 2022
Betel Gloves Nitrile Examination Glove Powder Free
K222342 · LZA
Betel Care Sdn. Bhd.
General Hospital · 52d
Cleared Sep 24, 2022
Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for...
K222294 · LZA
Onetexx Sdn Bhd
General Hospital · 54d
Cleared Sep 24, 2022
Nitrile Examination Glove, Pink Color
K221887 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 87d
Cleared Sep 24, 2022
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy...
K221718 · KGO
Hartalega NGC Sdn. Bhd.
General Hospital · 103d