Hsiner Co., Ltd. is one of 512 FDA 510(k) medical device manufacturers from Taiwan in the dataset, ranked by real submission volume.
Hsiner Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: VPAP Pediatric Face Mask, NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202, 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
7
Total
7
Cleared
0
Denied
Hsiner Co., Ltd. has 7 FDA 510(k) cleared medical devices. Based in Taichung City, TW.
Latest FDA clearance: Mar 2026. Active since 2005. Primary specialty: Anesthesiology.
Browse the FDA 510(k) cleared devices submitted by Hsiner Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Voler Biotech Consulting CO., Ltd. as regulatory consultant.
FDA 510(k) Regulatory Record - Hsiner Co., Ltd.
7 devices
Cleared
Mar 12, 2026
VPAP Pediatric Face Mask
Anesthesiology
265d
Cleared
Aug 12, 2011
NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK...
Anesthesiology
379d
Cleared
Jul 24, 2009
70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
General Hospital
92d
Cleared
Aug 22, 2008
HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS
Anesthesiology
30d
Cleared
Feb 23, 2007
CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
Anesthesiology
116d
Cleared
Mar 22, 2006
HSINER RESUSCITATOR
Anesthesiology
99d
Cleared
Dec 21, 2005
HSINER JET NEBULIZER, MODEL HS-31100
Anesthesiology
78d