Infinium Medical Inc

FDA Filings

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

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

• NANJING GOTRON MEDICAL EQUIPMENT CO. LTD.
• Suleyman Bilgutay
• Beijing National Medical Company LTD

FDA Registration(s)

• Registration Number: 1066427
• FEI Number: 3007513035
• Name: INFINIUM MEDICAL, INC.
• Owner & Operator: INFINIUM MEDICAL, INC.
• Contact Address: 12151 62ND ST N UNIT 5; Largo FL 33773 US
• Official Correspondent:
  • Oz Ozkaya
  • x-727-5318434-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 12151 62ND ST., N, UNIT 5; Largo, FL 33773 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00852087007607 INFINIUM MEDICAL, INC.	Edge	2023-06-23
GUDID 00852087007591 INFINIUM MEDICAL, INC.	Edge	2023-06-23
GUDID 00852087007584 INFINIUM MEDICAL, INC.	Edge	2023-06-23
GUDID 00852087007577 INFINIUM MEDICAL, INC.	Edge	2023-06-23
GUDID 00852087007522 INFINIUM MEDICAL, INC.	Infinium Medical	2021-12-22
GUDID 00852087007171 INFINIUM MEDICAL, INC.	Schiller Americas	2020-02-06
GUDID 00852087007119 INFINIUM MEDICAL, INC.	Schiller Americas	2020-02-06
GUDID 00852087007102 INFINIUM MEDICAL, INC.	Schiller Americas	2020-02-06
GUDID 00852087007096 INFINIUM MEDICAL, INC.	Axia	2020-02-06
GUDID 00852087007089 INFINIUM MEDICAL, INC.	Axia	2020-02-06
GUDID 00852087007072 INFINIUM MEDICAL, INC.	Axia	2020-02-06
GUDID 00852087007065 INFINIUM MEDICAL, INC.	Axia	2020-02-06
GUDID 00852087007058 INFINIUM MEDICAL, INC.	Infinium Medical	2020-02-06
GUDID 00852087007041 INFINIUM MEDICAL, INC.	Infinium Medical	2020-02-06
GUDID 00852087007034 INFINIUM MEDICAL, INC.	Infinium Medical	2020-02-06
GUDID 00852087007027 INFINIUM MEDICAL, INC.	Infinium Medical	2020-02-06
GUDID 00852087007010 INFINIUM MEDICAL, INC.	Infinium Medical	2020-02-06
GUDID 00852087007003 INFINIUM MEDICAL, INC.	Infinium Medical	2020-02-06
GUDID 00820870070345 INFINIUM MEDICAL, INC.	Infinium Medical	2018-03-29
CCW INFINIUM MEDICAL, INC.	ClearVue Video Laryngoscope	2017-01-19
PMN K131790 | BSZ INFINIUM MEDICAL, INC.	ADS II	2016-07-05
PMN K142244 | MWI INFINIUM MEDICAL, INC.	CLEO	2015-02-09
PMN K113485 | DPS INFINIUM MEDICAL, INC.	QRS12	2015-02-09
OUG INFINIUM MEDICAL, INC.	OMNIVIEW Hospital MDDS	2012-09-18
PMN K112329 | MWI INFINIUM MEDICAL, INC.	Omni, Omni K	2012-07-31
PMN K112329 | FLL INFINIUM MEDICAL, INC.	Omni, Omni K	2012-07-31
PMN K112329 | DXN INFINIUM MEDICAL, INC.	Omni, Omni K	2012-07-31
PMN K112329 | DQA INFINIUM MEDICAL, INC.	Omni, Omni K	2012-07-31
PMN K112329 | DPS INFINIUM MEDICAL, INC.	Omni, Omni K	2012-07-31
PMN K112329 | BZQ INFINIUM MEDICAL, INC.	Omni, Omni K	2012-07-31
PMN K103737 | MWI INFINIUM MEDICAL, INC.	Omni II	2011-06-03
PMN K103737 | MWI INFINIUM MEDICAL, INC.	Omni II K	2011-06-03
GDC INFINIUM MEDICAL, INC.	ATS	2011-05-17
PMN K103268 | MWI INFINIUM MEDICAL, INC.	Omni VS	2010-12-09
PMN K103268 | MWI INFINIUM MEDICAL, INC.	Omni Express	2010-12-09
PMN K101052 | MWI INFINIUM MEDICAL, INC.	Omni III	2010-09-13

Related Finance Registrations

CAGE Code

4BDJ9

INFINIUM MEDICAL, INC. 33773-3702

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009098531	Yantian,China (Mainland) -> Tampa, Florida	ROLLING STAND EMPTY CARTON BOX	26 PKG
2020090418243	Shanghai ,China (Mainland) -> Miami, Florida	ANESTHESIA MACHINE ADSII	6 PKG
202008129359	Shanghai ,China (Mainland) -> Miami, Florida	PARTS FOR VETERINARY MONITOR;PARTS FOR MONITO .	110 CTN
202008104218	Shanghai ,China (Mainland) -> Miami, Florida	MULTI-PARAMETER MONITOR	260 CTN
2020080819460	Yantian,China (Mainland) -> Tampa, Florida	ROLLING STAND	192 CTN
202007187941	Shanghai ,China (Mainland) -> Miami, Florida	PATIENT MONITOR WITH ACCESSORIES	115 CTN
202007187900	Shanghai ,China (Mainland) -> Miami, Florida	WALL MOUNT	4 PKG
2020071019643	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	LITHIUM ION BATTERY	27 CTN