Makrite Industries, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Makrite Industries, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Disposable Medical Face Mask, Disposable Medical Face Mask (M643BE), Disposable Surgical Face Mask (M663BE, M663BT)
4
Total
4
Cleared
0
Denied
Makrite Industries, Inc. has 4 FDA 510(k) cleared medical devices. Based in Webster, US.
Latest FDA clearance: Jan 2026. Active since 2002. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Makrite Industries, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Shanghai Sungo Management Consulting Company Limited. and Shanghai SUNGO Management Consulting Co., Ltd..
FDA 510(k) Regulatory Record - Makrite Industries, Inc.
4 devices
Cleared
Jan 05, 2026
Disposable Medical Face Mask
General Hospital
136d
Cleared
Apr 18, 2024
Disposable Medical Face Mask (M643BE)
General Hospital
78d
Cleared
Jun 14, 2022
Disposable Surgical Face Mask (M663BE, M663BT)
General Hospital
109d
Cleared
Jul 23, 2002
MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95
General Hospital
161d