Baui Biotech Co L T D

FDA Filings

This page includes the latest FDA filings for Baui Biotech Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013514648
• FEI Number: 3013514648
• Name: BAUI BIOTECH CO., LTD.
• Owner & Operator: BAUI BIOTECH CO., LTD.
• Contact Address: 6F., No.6, Sec.1, Zhongxing Rd. Wugu Dist.; New Taipei City TW-TPQ Taipei - District 24872 TW
• Official Correspondent:
  • Herman Jhan
  • 886-2-89769538-154
• US Agent:
  • Ho Shan Wang
  • 623 9864377
  • acmebiotechs@gmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 6F., No.8, Sec.1, Zhongxing Rd. Wugu Dist.; New Taipei City, Taipei - District, 24872 TW
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 04719883858610 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04719883855428 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04719883855411 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04719883337429 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04719883337399 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04719883337382 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04719883337320 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04719883337313 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04719883333063 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005155484 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005155330 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005155309 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005155262 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005155255 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005155248 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005155231 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005155224 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005155217 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005155200 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005155194 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005153985 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005153794 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005152889 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005152872 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005151905 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04718005151899 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04715862873735 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04715862873629 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04715862873575 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04715862873568 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04715862873537 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04715862873414 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04715862873407 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04715862873353 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04715862873308 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04715862873209 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04715862873193 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04715862873094 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04715862873025 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04715862871625 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04715862871601 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04712899256838 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04712899253257 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04712899253172 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04712899253158 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04712899253110 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04710577044616 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04710577043619 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04710577043558 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04710577043510 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04710577043503 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04710577043473 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04710577043404 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04710577043398 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04710577043381 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04710577043374 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04710577043282 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04710577041691 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04710577041677 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04710577040953 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04710577040939 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-23
GUDID 04719883865779 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2025-01-22
GUDID 04719883865762 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2025-01-22
GUDID 04719883865755 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2025-01-22
GUDID 04719883865748 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2025-01-22
GUDID 04719883865731 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2025-01-22
GUDID 04719883854803 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04719883854797 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04719883337306 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04719883337290 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04719883337283 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04719883337276 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04719883337269 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04719883337252 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04719883337245 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04719883337238 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04719883337221 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04719883337214 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04719883337207 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04719883337191 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04719883337177 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159888 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159871 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159864 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159857 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159840 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159833 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159826 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159819 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159802 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159789 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159772 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159765 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159758 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159710 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159703 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159697 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005159680 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04718005155156 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
GUDID 04710577045989 BAUI BIOTECH CO. LTD.	Orthopedic manual surgical instrument	2025-01-22
PMN K191353 BAUI Biotech Co., Ltd.	COMET Lumbar Interbody Fusion Cage	2020-04-14
PMN K191494 Baui Biotech Co., Ltd.	Facilis™ Spinal System	2019-08-12
PMN K182416 BAUI Biotech CO., LTD.	NOVA Minimally Invasive System	2019-06-11
LXH BAUI BIOTECH CO., LTD.	compression Device	2017-10-27
LXH BAUI BIOTECH CO., LTD.	T-type Torque Wrench	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Sensor	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Rod Template	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Rod Pusher	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Rod Pusher 5mm Hex Simple Screw Driver	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Rod Holder	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Rod Bender	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Reduction Forceps	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Probe	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Probe(curved)	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Poly Axial Screw Driver	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Poly Axial Screw Driver/Cannulated Screw	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Poly Axial Screw Adjustable Driver	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Mono Axial Screw Driver	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Handle	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Gun-type Pull-up Pliers	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Distraction Device	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Development Pin Implanter	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Depth Sounder	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Blade Breaker	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Bending Iron, right	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Bending Iron, left	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Awl(with stop)	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Anti-Rotator Wrench	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Anti-Rotator Pliers	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Adjustable Rod Bender	2017-10-27
LXH BAUI BIOTECH CO., LTD.	8mm Hex Socket Screw Driver	2017-10-27
LXH BAUI BIOTECH CO., LTD.	7mm Tap	2017-10-27
LXH BAUI BIOTECH CO., LTD.	6mm Tap	2017-10-27
LXH BAUI BIOTECH CO., LTD.	5mm Tap	2017-10-27
LXH BAUI BIOTECH CO., LTD.	5mm Socket Wrench	2017-10-27
LXH BAUI BIOTECH CO., LTD.	5mm Rotator Bar	2017-10-27
LXH BAUI BIOTECH CO., LTD.	5mm Hex Screw Driver	2017-10-27
LXH BAUI BIOTECH CO., LTD.	4mm Tap	2017-10-27
LXH BAUI BIOTECH CO., LTD.	4mm Pin Guide	2017-10-27
LXH BAUI BIOTECH CO., LTD.	3mm Hex screw Driver	2017-10-27
PMN K161231 | NKB BAUI BIOTECH CO., LTD.	FACILIS SPINAL SYSTEM	2017-02-13
PMN K161231 | KWP BAUI BIOTECH CO., LTD.	FACILIS SPINAL SYSTEM	2017-02-13
PMN K161231 BAUI BIOTECH CO., LTD.	Facilis™ Spinal System	2017-01-23