Waismed L T D

FDA Filings

This page includes the latest FDA filings for Waismed 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: 9616791
• FEI Number: 3001316486
• Name: Ofer Molad
• Owner & Operator: WAISMED LTD.
• Contact Address: 10 Amal St. Afek Industrial Park; Rosh HaAyin IL-M HaMerkaz 4809234 IL
• Official Correspondent:
  • Einat - Swisa
  • 972-9-9517444-0
• US Agent:
  • Ofer Molad
  • PerSys Medical
  • 713 7236000 250
  • 713 7236221
  • ofer@ps-med.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5310 Elm St ; HOUSTON, TX 77081 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K211968 WaisMed Ltd	NIO+ Adult	2021-07-22
GUDID 27290008325107 WaisMed Ltd	GOIO	2021-04-14
GUDID 07290008325097 WaisMed Ltd	NIO Fixation	2020-08-18
GUDID 07290008325080 WaisMed Ltd	NIO	2020-08-18
GUDID 07290008325066 WaisMed Ltd	NIO	2019-11-19
PMN K190538 | MHC Ofer Molad [WAISMED LTD.]	NIO Infant	2019-10-28
PMN K190538 | FMI Ofer Molad [WAISMED LTD.]	NIO Infant	2019-10-28
PMN K190538 WaisMed Ltd	NIO-I	2019-10-07
GUDID 17290008325056 WaisMed Ltd	NIO	2018-07-06
GUDID 17290008325049 WaisMed Ltd	B.I.G.	2018-07-06
GUDID 17290008325032 WaisMed Ltd	B.I.G.	2018-07-06
GUDID 17290008325025 WaisMed Ltd	NIO	2018-07-06
GUDID 27290008325015 WaisMed Ltd	GOIO	2018-03-29
PMN K160805 | FMI Ofer Molad [WAISMED LTD.]	NIO-P- Pediatric Intraosseous Device	2016-06-27
PMN K160805 WAISMED LTD.	NIO-P	2016-06-23
OJA Ofer Molad [WAISMED LTD.]	Go io	2016-01-25
GAX Ofer Molad [WAISMED LTD.]	Secure IV	2015-11-08
KMK Ofer Molad [WAISMED LTD.]	NIO FIXATION	2015-09-01
PMN K142086 | FMI Ofer Molad [WAISMED LTD.]	NIO	2015-05-14
PMN K142086 WAISMED LTD.	NIO -INTRAOSSEOUS DEVICE	2014-08-28
PMN K062940 | FMI Ofer Molad [WAISMED LTD.]	B.I.G. (BONE INJECTION GUN)	2008-10-22
PMN K062940 WAISMED LTD.	BONE INJECTION GUN (B.I.G.)	2006-12-22
PMN K022415 WAISMED LTD.	BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST	2002-10-11
PMN K981853 | FMI Ofer Molad [WAISMED LTD.]	B.I.G (BONE INJECTION GUN)	1999-02-04
PMN K022415 | FMI Ofer Molad [WAISMED LTD.]	B.I.G (BONE INJECTION GUN)	1999-02-04
PMN K981853 WAISMED LTD.	BONE INJECTION GUN (B.I.G.) DEVICE	1998-11-17

Related Finance Registrations

NCAGE Code	3037A	WAISMED LTD.
NCAGE Code	SQR61	WAISMED LTD.
CAGE Code	SQR61	WAISMED LTD.
CAGE Code	3037A	WAISMED LTD.