Dukal Corporation is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Dukal Corporation - FDA 510(k) Cleared Devices
Recent clearances: Dukal Corporation AAMI Level 4 Open-Back Protective Gown, Dukal Corporation Level 1 Pediatric Face Mask, Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown
7
Total
7
Cleared
0
Denied
Dukal Corporation has 7 FDA 510(k) cleared medical devices. Based in Hauppauge, US.
Last cleared in 2022. Active since 2007. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Dukal Corporation Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Dukal Corporation
7 devices
Cleared
Mar 30, 2022
Dukal Corporation AAMI Level 4 Open-Back Protective Gown
General Hospital
236d
Cleared
Mar 29, 2022
Dukal Corporation Level 1 Pediatric Face Mask
General Hospital
418d
Cleared
Mar 18, 2022
Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3...
General Hospital
500d
Cleared
Feb 16, 2021
Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal...
General Hospital
236d
Cleared
Feb 05, 2021
Dukal Corporation Level 2 Surgical Mask with Ear Loops
General Hospital
252d
Cleared
May 04, 2012
DUKAL LUBRICATING JELLY
General Hospital
141d
Cleared
May 30, 2007
DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK
General Hospital
78d