Onyx Medical Inc

FDA Filings

This page includes the latest FDA filings for Onyx Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Onyx Medical Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• ROGER MACHSON

FDA Registration(s)

• Registration Number: 2951557
• FEI Number: 1000307124
• Name: ONYX MEDICAL INC.
• Owner & Operator: ONYX MEDICAL INC.
• Contact Address: 16 Digital Drive, Suite 120 --; Novato CA 94949 US
• Official Correspondent:
  • ROGER - MACHSON
  • x-415-8844412-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 16 Digital Drive Suite 120; Novato, CA 94949 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K101901 | ONF ONYX MEDICAL INC.	Extra 818- IPL	2013-01-28
PMN K101901 | ONF ONYX MEDICAL INC.	Bright Light- IPL	2013-01-28
PMN K083590 | GEI ONYX MEDICAL INC.	LTF- Radio Frequency	2013-01-28
PMN K083590 | GEI ONYX MEDICAL INC.	LDT- Radio Frequency	2013-01-28
PMN K050950 | GEX ONYX MEDICAL INC.	Optima- IPL	2013-01-28
ISA ONYX MEDICAL INC.	Pluse- Electrical Massager	2013-01-28
ISA ONYX MEDICAL INC.	LDT- Vacuum Massager	2013-01-28
LYU ONYX MEDICAL INC.	Face Shields	1994-10-07

Related Finance Registrations

NCAGE Code	0XVC5	ONYX MEDICAL INC
CAGE Code	0XVC5	ONYX MEDICAL INC
S.A.M. Registration	0XVC5 [957115228]	ONYX MEDICAL INC
DUNS	957115228	ONYX MEDICAL INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092840991	Shanghai ,China (Mainland) -> Oakland, California	FACE DRAPE	400 CTN
2020090738015	Shanghai ,China (Mainland) -> Oakland, California	FACE DRAPE	400 CTN
2020081422693	Shanghai ,China (Mainland) -> Oakland, California	FACE DRAPE	400 CTN
2020080334585	Shanghai ,China (Mainland) -> Oakland, California	FACE DRAPE	400 CTN
2020061125247	Ningpo ,China (Mainland) -> Oakland, California	FACE DRAPE FACE DRAPE @FAX 021-33872221	400 CTN
2019033026688	Shanghai ,China (Mainland) -> Oakland, California	FACE DRAPE	400 CTN
2019021117463	Shanghai ,China (Mainland) -> Oakland, California	FACE DRAPE	400 CTN
2018122028708	Shanghai ,China (Mainland) -> Oakland, California	FACE DRAPE	360 CTN