FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
793–816 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 07, 2023
BD SmartSite™ Needle-Free Connector
K223088 · FPA
Care Fusion
General Hospital · 189d
Cleared Apr 06, 2023
Disposable Insulin Pen Needle
K222739 · FMI
Hantech Medical Device Co., Ltd.
General Hospital · 209d
Cleared Mar 31, 2023
Spectrum IQ Infusion System with Dose IQ Safety Software
K230041 · FRN
Baxter Healthcare Corporation
General Hospital · 84d
Cleared Mar 31, 2023
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
K230022 · FRN
Baxter Healthcare Corporation
General Hospital · 86d
Cleared Mar 30, 2023
Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with...
K220088 · LZA
Professional Latex Sdn Bhd
General Hospital · 443d
Not Cleared Mar 30, 2023
SNOO Smart Sleeper
DEN210039 · QTG
Happiest Baby, Inc.
General Hospital · 556d
Cleared Mar 28, 2023
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
K230582 · MED
STERIS Corporation
General Hospital · 26d
Cleared Mar 27, 2023
Disposable Surgical Face Mask
K223823 · FXX
Efofex, Inc.
General Hospital · 96d
Cleared Mar 25, 2023
Vinyl examination gloves
K230046 · LYZ
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 78d
Cleared Mar 25, 2023
Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use,...
K220644 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 386d
Cleared Mar 24, 2023
Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for...
K230002 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 80d
Cleared Mar 24, 2023
Blood Collection Needle (with/without Needle Holder)
K223323 · JKA
Anhui Hongyu Wuzhou Medical...
General Hospital · 144d
Cleared Mar 24, 2023
Medline Surgical Face Mask and Medline Procedural Face Mask
K223236 · FXX
Medline Industries, LP
General Hospital · 156d
Cleared Mar 24, 2023
BD Texium™ Closed Male Luer
K223076 · ONB
Care Fusion
General Hospital · 175d
Cleared Mar 24, 2023
BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button...
K220212 · JKA
Becton, Dickinson and Company
General Hospital · 422d
Cleared Mar 23, 2023
Disposable Medical Nitrile Examination Gloves
K223895 · LZA
Hebei Titans Hongsen Medical...
General Hospital · 85d
Cleared Mar 23, 2023
Sterilized Latex Surgical Gloves
K222620 · KGO
Suzhou Colour-Way New Material Co., Ltd.
General Hospital · 205d
Cleared Mar 23, 2023
Sterilization Wrap
K222151 · FRG
Kenpax International Limited
General Hospital · 246d
Cleared Mar 23, 2023
Sterile Hypodermic Syringe for Single Use
K212207 · FMF
Shandong Weigao Group Medical Polymer...
General Hospital · 616d
Cleared Mar 21, 2023
Instrument Case P1340904
K223672 · KCT
Cochlear
General Hospital · 104d
Cleared Mar 20, 2023
Shina Safety Needle
K222417 · FMI
Shina Corporation
General Hospital · 222d
Cleared Mar 16, 2023
Nitrile Examination Gloves
K222813 · LZA
Ecoglove Medical Manufacturing...
General Hospital · 178d
Cleared Mar 15, 2023
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low...
K223375 · LZA
Kossan International Sdn Bhd3
General Hospital · 131d
Cleared Mar 15, 2023
Tegamen Nitrile Examination Gloves
K223102 · LZA
M/S Tegamen Safety Products Private...
General Hospital · 166d