MacroLux Medical Technology Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
MacroLux Medical Technology Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG), CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B), SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
6
Total
6
Cleared
0
Denied
MacroLux Medical Technology Co., Ltd. has 6 FDA 510(k) cleared medical devices. Based in Shenzhen, CN.
Latest FDA clearance: Apr 2026. Active since 2024. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by MacroLux Medical Technology Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Chonconn Medical Device Consulting Co., Ltd. as regulatory consultant.
FDA 510(k) Regulatory Record - MacroLux Medical Technology Co., Ltd.
6 devices
Cleared
Apr 08, 2026
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
Ear, Nose, Throat
58d
Cleared
Jun 02, 2025
CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B,...
Gastroenterology & Urology
104d
Cleared
Aug 16, 2024
SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G,...
Obstetrics & Gynecology
128d
Cleared
Jun 10, 2024
BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB,...
Gastroenterology & Urology
130d
Cleared
Apr 05, 2024
LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C,...
Ear, Nose, Throat
130d
Cleared
Jan 11, 2024
CoralView® Single-use Digital Flexible Ureteroscope (U10)
Gastroenterology & Urology
209d