Shanghai Kinetic Medical Co L T D

FDA Filings

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

CHINA

SHENZHEN STOCK EXCHANGE

300326

DUNS 528198569

FDA Registration(s)

• Registration Number: 3010071016
• FEI Number: 3010071016
• Name: SHANGHAI KiNETIC MEDICAL CO LTD
• Owner & Operator: Shanghai Kinetic Medical Co LTD
• Contact Address: 2F, No.23 Building, 528 Ruiqing Road East Zhangjiang High-Tech Park; East Zhangjiang CN-31 Shanghai 201201 CN
• Official Correspondent:
  • Halley Feng
  • 86-158-00850004-x
• US Agent:
  • Gregory Mathison
  • Regulatory Strategies, Inc.
  • 218 3871559
  • gmathison@att.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2F, No.23 Building, 528 Ruiqing Road East Zhangjiang High-Tech Park; East Zhangjiang Shanghai, 201201 CN
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 06938695546654 Shanghai Kinetic Medical Co., Ltd.	KMC OneShot Single Balloon Assembly, 10 Gauge, 20mm	2020-10-09
GUDID 06938695546647 Shanghai Kinetic Medical Co., Ltd.	KMC OneShot Single Balloon Assembly, 10 Gauge, 15mm	2020-10-09
GUDID 06938695546630 Shanghai Kinetic Medical Co., Ltd.	KMC OneShot Single Balloon Assembly, 10 Gauge, 10mm	2020-10-09
GUDID 06938695546623 Shanghai Kinetic Medical Co., Ltd.	KMC OneShot Double Balloon Assembly, 10 Gauge, 20mm	2020-10-09
GUDID 06938695546616 Shanghai Kinetic Medical Co., Ltd.	KMC OneShot Double Balloon Assembly, 10 Gauge, 15mm	2020-10-09
GUDID 06938695546609 Shanghai Kinetic Medical Co., Ltd.	KMC OneShot Double Balloon Assembly, 10 Gauge, 10mm	2020-10-09
GUDID 06938695546593 Shanghai Kinetic Medical Co., Ltd.	KMC OneShot Single Balloon Assembly, 8 Gauge, 20mm	2020-10-09
GUDID 06938695546586 Shanghai Kinetic Medical Co., Ltd.	KMC OneShot Single Balloon Assembly, 8 Gauge, 15mm	2020-10-09
GUDID 06938695546579 Shanghai Kinetic Medical Co., Ltd.	KMC OneShot Single Balloon Assembly, 8 Gauge, 10mm	2020-10-09
GUDID 06938695546562 Shanghai Kinetic Medical Co., Ltd.	KMC OneShot Double Balloon Assembly, 8 Gauge, 20mm	2020-10-09
GUDID 06938695546555 Shanghai Kinetic Medical Co., Ltd.	KMC OneShot Double Balloon Assembly, 8 Gauge, 15mm	2020-10-09
GUDID 06938695546548 Shanghai Kinetic Medical Co., Ltd.	KMC OneShot Double Balloon Assembly, 8 Gauge, 10mm	2020-10-09
GUDID 06938695546531 Shanghai Kinetic Medical Co., Ltd.	KMC Single Balloon Assembly, 8 Gauge, 20mm	2020-10-09
GUDID 06938695546524 Shanghai Kinetic Medical Co., Ltd.	KMC Single Balloon Assembly, 8 Gauge, 15mm	2020-10-09
GUDID 06938695546517 Shanghai Kinetic Medical Co., Ltd.	KMC Single Balloon Assembly, 8 Gauge, 10mm	2020-10-09
GUDID 06938695546500 Shanghai Kinetic Medical Co., Ltd.	KMC Double Balloon Assembly, 8 Gauge, 20mm	2020-10-09
GUDID 06938695546494 Shanghai Kinetic Medical Co., Ltd.	KMC Double Balloon Assembly, 8 Gauge, 15mm	2020-10-09
GUDID 06938695546487 Shanghai Kinetic Medical Co., Ltd.	KMC Double Balloon Assembly, 8 Gauge, 10mm	2020-10-09
GUDID 06938695546470 Shanghai Kinetic Medical Co., Ltd.	KMC Multipurpose Tool, 7 Gauge, 22/23mm	2020-10-09
GUDID 06938695546463 Shanghai Kinetic Medical Co., Ltd.	KMC Multipurpose Tool, 7 Gauge, 16/14mm	2020-10-09
GUDID 06938695546456 Shanghai Kinetic Medical Co., Ltd.	KMC Curved Curette	2020-10-09
GUDID 06938695546449 Shanghai Kinetic Medical Co., Ltd.	KMC Curette	2020-10-09
GUDID 06938695546432 Shanghai Kinetic Medical Co., Ltd.	KMC Biopsy Device, 10 Gauge, Trephine Tip	2020-10-09
GUDID 06938695546425 Shanghai Kinetic Medical Co., Ltd.	KMC Biopsy Device, 8 Gauge, Square Tip	2020-10-09
GUDID 06938695546418 Shanghai Kinetic Medical Co., Ltd.	KMC Biopsy Device, 8 Gauge, Trephine Tip	2020-10-09
GUDID 06938695546401 Shanghai Kinetic Medical Co., Ltd.	KMC Bone Filler Device, 10 Gauge, Flat Tip	2020-10-09
GUDID 06938695546395 Shanghai Kinetic Medical Co., Ltd.	KMC Bone Filler Device, 8 Gauge, Lateral Open Tip	2020-10-09
GUDID 06938695546388 Shanghai Kinetic Medical Co., Ltd.	KMC Bone Filler Device, 8 Gauge, Flat Tip	2020-10-09
GUDID 06938695546371 Shanghai Kinetic Medical Co., Ltd.	KMC Bone Filler Device, 8 Gauge, Bevel Tip	2020-10-09
GUDID 06938695546364 Shanghai Kinetic Medical Co., Ltd.	KMC Drill, 10 Gauge, 200mm	2020-10-09
GUDID 06938695546357 Shanghai Kinetic Medical Co., Ltd.	KMC Drill, 8 Gauge, 220mm	2020-10-09
GUDID 06938695546340 Shanghai Kinetic Medical Co., Ltd.	KMC Drill, 8 Gauge, 200mm	2020-10-09
GUDID 06938695546333 Shanghai Kinetic Medical Co., Ltd.	KMC OneShot Working Channel, 10 Gauge, Pyramid Tip	2020-10-09
GUDID 06938695546326 Shanghai Kinetic Medical Co., Ltd.	KMC OneShot Working Channel, 10 Gauge, Bevel Tip	2020-10-09
GUDID 06938695546319 Shanghai Kinetic Medical Co., Ltd.	KMC OneShot Working Channel, 8 Gauge, Pyramid Tip	2020-10-09
GUDID 06938695546302 Shanghai Kinetic Medical Co., Ltd.	KMC OneShot Working Channel, 8 Gauge, Bevel Tip	2020-10-09
GUDID 06938695546296 Shanghai Kinetic Medical Co., Ltd.	KMC Working Channel with Cannula, 8 Gauge	2020-10-09
GUDID 06938695546289 Shanghai Kinetic Medical Co., Ltd.	KMC Working Channel, 10 Gauge	2020-10-09
GUDID 06938695546272 Shanghai Kinetic Medical Co., Ltd.	KMC Working Channel, 8 Gauge	2020-10-09
GUDID 06938695546265 Shanghai Kinetic Medical Co., Ltd.	KMC Inflation Syringe, 60cm, 30atm	2020-10-09
GUDID 06938695546258 Shanghai Kinetic Medical Co., Ltd.	KMC Inflation Syringe, 30cm, 30atm	2020-10-09
GUDID 06938695546241 Shanghai Kinetic Medical Co., Ltd.	KMC Balloon Catheter Curved, 10 Gauge, 45°, 25mm	2020-10-09
GUDID 06938695546234 Shanghai Kinetic Medical Co., Ltd.	KMC Balloon Catheter Curved, 10 Gauge, 45°, 20mm	2020-10-09
GUDID 06938695546227 Shanghai Kinetic Medical Co., Ltd.	KMC Balloon Catheter Curved, 10 Gauge, 45°, 15mm	2020-10-09
GUDID 06938695546210 Shanghai Kinetic Medical Co., Ltd.	KMC Balloon Catheter, 10 Gauge, 20mm	2020-10-09
GUDID 06938695546203 Shanghai Kinetic Medical Co., Ltd.	KMC Balloon Catheter, 10 Gauge, 15mm	2020-10-09
GUDID 06938695546197 Shanghai Kinetic Medical Co., Ltd.	KMC Balloon Catheter, 10 Gauge, 10mm	2020-10-09
GUDID 06938695546180 Shanghai Kinetic Medical Co., Ltd.	KMC Balloon Catheter, 8 Gauge, 20mm	2020-10-09
GUDID 06938695546173 Shanghai Kinetic Medical Co., Ltd.	KMC Balloon Catheter, 8 Gauge, 15mm	2020-10-09
GUDID 06938695546166 Shanghai Kinetic Medical Co., Ltd.	KMC Balloon Catheter, 8 Gauge, 10mm	2020-10-09
GUDID 06938695546159 Shanghai Kinetic Medical Co., Ltd.	KMC Access Needle, 13 Gauge, 115mm, Integrated Bevel Tip	2020-10-09
GUDID 06938695546142 Shanghai Kinetic Medical Co., Ltd.	KMC Access Needle, 13 Gauge, 115mm, Pyramid Tip	2020-10-09
GUDID 06938695546135 Shanghai Kinetic Medical Co., Ltd.	KMC Access Needle, 13 Gauge, 95mm, Pyramid Tip	2020-10-09
GUDID 06938695546128 Shanghai Kinetic Medical Co., Ltd.	KMC Access Needle, 11 Gauge, 115mm, Integrated Bevel Tip	2020-10-09
GUDID 06938695546111 Shanghai Kinetic Medical Co., Ltd.	KMC Access Needle, 11 Gauge, 115mm, Integrated Diamond Tip	2020-10-09
GUDID 06938695546104 Shanghai Kinetic Medical Co., Ltd.	KMC Access Needle, 11 Gauge, 115mm, Pyramid Tip	2020-10-09
GUDID 06938695546098 Shanghai Kinetic Medical Co., Ltd.	KMC Access Needle, 11 Gauge, 95mm, Pyramid Tip	2020-10-09
GUDID 06938695546081 Shanghai Kinetic Medical Co., Ltd.	KMC Access Needle, 11 Gauge, 95mm, Bevel Tip	2020-10-09
GUDID 06938695546074 Shanghai Kinetic Medical Co., Ltd.	KMC Guide Wire, 1.6mm, Sharp Tip	2020-10-09
GUDID 06938695546067 Shanghai Kinetic Medical Co., Ltd.	KMC Guide Wire, 1.6mm, Blunt Tip	2020-10-09
GUDID 06938695540317 Shanghai Kinetic Medical Co., Ltd.	Multifunctional Tool FG5401	2020-06-08
GUDID 06938695540300 Shanghai Kinetic Medical Co., Ltd.	Multifunctional Tool FG5400	2020-06-08
GUDID 06938695537874 Shanghai Kinetic Medical Co., Ltd.	Bone Biopsy Device BC1111	2020-06-08
GUDID 06938695537867 Shanghai Kinetic Medical Co., Ltd.	Curved Curette VO1113	2020-06-08
GUDID 06938695537850 Shanghai Kinetic Medical Co., Ltd.	Balloon Catheter Curved LC10225	2020-06-08
GUDID 06938695537843 Shanghai Kinetic Medical Co., Ltd.	Balloon Catheter Curved LC10220	2020-06-08
GUDID 06938695537836 Shanghai Kinetic Medical Co., Ltd.	Balloon Catheter Curved LC10215	2020-06-08
GUDID 06938695537829 Shanghai Kinetic Medical Co., Ltd.	Balloon Catheter FA1120	2020-06-08
GUDID 06938695537812 Shanghai Kinetic Medical Co., Ltd.	Balloon Catheter FA1115	2020-06-08
GUDID 06938695537805 Shanghai Kinetic Medical Co., Ltd.	Balloon Catheter FA1110	2020-06-08
GUDID 06938695537799 Shanghai Kinetic Medical Co., Ltd.	Curette FG9011	2020-06-08
GUDID 06938695537782 Shanghai Kinetic Medical Co., Ltd.	Balloon Catheter Syringe Pump FG4013	2020-06-08
GUDID 06938695537775 Shanghai Kinetic Medical Co., Ltd.	Balloon Catheter Syringe Pump FG4011	2020-06-08
GUDID 06938695537768 Shanghai Kinetic Medical Co., Ltd.	Access Needle FG3019	2020-06-08
GUDID 06938695537751 Shanghai Kinetic Medical Co., Ltd.	Access Needle FG3018	2020-06-08
GUDID 06938695537744 Shanghai Kinetic Medical Co., Ltd.	Access Needle FG3016	2020-06-08
GUDID 06938695537737 Shanghai Kinetic Medical Co., Ltd.	One-Shot FG2711	2020-06-08
GUDID 06938695537720 Shanghai Kinetic Medical Co., Ltd.	One-Shot FG2710	2020-06-08
GUDID 06938695537713 Shanghai Kinetic Medical Co., Ltd.	Bone Filler Device FG2513	2020-06-08
GUDID 06938695537706 Shanghai Kinetic Medical Co., Ltd.	Bone Filler Device FG2512	2020-06-08
GUDID 06938695537690 Shanghai Kinetic Medical Co., Ltd.	Bone Biopsy Device FG2511	2020-06-08
GUDID 06938695537683 Shanghai Kinetic Medical Co., Ltd.	Bone Filler Device FG2510	2020-06-08
GUDID 06938695537676 Shanghai Kinetic Medical Co., Ltd.	Dilator w/Cannula FG2410	2020-06-08
GUDID 06938695537669 Shanghai Kinetic Medical Co., Ltd.	Cannula FG2210	2020-06-08
GUDID 06938695537652 Shanghai Kinetic Medical Co., Ltd.	Drill FG2111	2020-06-08
GUDID 06938695537645 Shanghai Kinetic Medical Co., Ltd.	Drill FG2110	2020-06-08
GUDID 06938695540058 Shanghai Kinetic Medical Co., Ltd.	KMC Medical Balloon Catheter Syringe Pump FG4003	2020-05-06
GUDID 06938695540010 Shanghai Kinetic Medical Co., Ltd.	KMC Medical Balloon Catheter Syringe Pump	2020-05-06
GUDID 06938695520012 Shanghai Kinetic Medical Co., Ltd.	Tool Kit	2020-01-14
GUDID 06938695525017 Shanghai Kinetic Medical Co., Ltd.	Bone Filler Device FG2501	2019-02-07
GUDID 06938695525000 Shanghai Kinetic Medical Co., Ltd.	Bone Filler Device FG2500	2019-02-07
FWZ SHANGHAI KiNETIC MEDICAL CO LTD	Arthroscopic Leg Holder System	2018-12-14
GUDID 06938695510822 Shanghai Kinetic Medical Co., Ltd.	Puncture Needle FG3007	2018-07-06
GUDID 06938695510815 Shanghai Kinetic Medical Co., Ltd.	Puncture Needle FG3005	2018-07-06
GUDID 06938695510808 Shanghai Kinetic Medical Co., Ltd.	Puncture Needle FG3003	2018-07-06
GUDID 06938695510204 Shanghai Kinetic Medical Co., Ltd.	Balloon Catheter FG1001-20	2018-07-06
GUDID 06938695510150 Shanghai Kinetic Medical Co., Ltd.	Balloon Catheter FG1001-15	2018-07-06
GUDID 06938695510105 Shanghai Kinetic Medical Co., Ltd.	Balloon Catheter FG1001-10	2018-07-06
GUDID 06938695501523 Shanghai Kinetic Medical Co., Ltd.	KMC Kyphoplasty System FG0005-10	2018-07-06
GUDID 06938695500144 Shanghai Kinetic Medical Co., Ltd.	KMC Kyphoplasty System FG0005-20	2018-07-06
GUDID 06938695500137 Shanghai Kinetic Medical Co., Ltd.	KMC Kyphoplasty System FG0005-15	2018-07-06
OAR SHANGHAI KiNETIC MEDICAL CO LTD	KMC Bone Cement Delivery System	2016-12-18
KIH SHANGHAI KiNETIC MEDICAL CO LTD	Bone Cement Injection Gun	2016-12-18
LXH SHANGHAI KiNETIC MEDICAL CO LTD	KMC VERTEBRAL OSTEOTOME	2016-11-06
LXH SHANGHAI KiNETIC MEDICAL CO LTD	KMC Curet	2016-11-06
PMN K113742 | NDN SHANGHAI KiNETIC MEDICAL CO LTD	KMC Kyphoplasty System	2016-01-22
PMN K113742 | HRX SHANGHAI KiNETIC MEDICAL CO LTD	KMC Kyphoplasty System	2016-01-22
PMN K113742 SHANGHAI KINETIC MEDICAL CO., LTD	KMC KYPHOPLASTY SYSTEM	2012-09-17