Ksg Medicare Sdn. Bhd. is one of 78 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Ksg Medicare Sdn. Bhd. - FDA 510(k) Cleared Devices
Recent clearances: Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue), Powder Free Nitrile Examination Glove, Non-sterile (Blue), Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)
3
Total
3
Cleared
0
Denied
Ksg Medicare Sdn. Bhd. has 3 FDA 510(k) cleared medical devices. Based in Tangkak, MY.
Latest FDA clearance: Sep 2024. Active since 2022. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Ksg Medicare Sdn. Bhd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Truscott Medsci Associates, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Ksg Medicare Sdn. Bhd.
3 devices
Cleared
Sep 11, 2024
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46...
General Hospital
85d
Cleared
Apr 11, 2022
Powder Free Nitrile Examination Glove, Non-sterile (Blue)
General Hospital
75d
Cleared
Mar 26, 2022
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with...
General Hospital
59d