Datex Ohmeda

FDA Filings

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

FDA Filings

Device Company	Device	Date
PMN K131945 DATEX-OHMEDA	GE DATEX-OHMEDA AVANCE CS2	2013-08-08
PMN K122445 DATEX-OHMEDA	AESPIRE 7900, AESPIRE VIEW	2012-10-12
PMN K111116 DATEX-OHMEDA	ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000	2011-09-09
PMN K071142 DATEX-OHMEDA	GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM	2007-06-06
PMN K042891 DATEX-OHMEDA	DATEX-OHMEDA OXY-AFR SENSOR	2005-06-29
PMN K043572 DATEX-OHMEDA	COMPATIBILITY ECG TRUNK CABLES	2005-02-22
PMN K043551 DATEX-OHMEDA	DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES	2005-02-18
PMN K043276 DATEX-OHMEDA	DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE	2004-12-23
PMN K042771 DATEX-OHMEDA	GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3	2004-10-15
PMN K041790 DATEX-OHMEDA	DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE	2004-07-23
PMN K032803 DATEX-OHMEDA	DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM	2004-03-10
PMN K033281 DATEX-OHMEDA	DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE	2003-11-26
PMN K033078 DATEX-OHMEDA	DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE	2003-10-29
PMN K031781 DATEX-OHMEDA	DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES	2003-06-25
PMN K030990 DATEX-OHMEDA	DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR	2003-06-25
PMN K031653 DATEX-OHMEDA	DATEX-OHMEDA HMEF 750	2003-06-20
PMN K030812 DATEX-OHMEDA	DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE	2003-05-21
PMN K023454 DATEX-OHMEDA	DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES	2003-04-23
PMN K023459 DATEX-OHMEDA	DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES	2003-01-13
PMN K023641 DATEX-OHMEDA	DATEX-OHMEDA HMEF MINI	2002-11-27
PMN K022740 DATEX-OHMEDA	DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE	2002-11-14
PMN K023497 DATEX-OHMEDA	DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE	2002-11-04
PMN K022485 DATEX-OHMEDA	DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE	2002-10-03
PMN K021265 DATEX-OHMEDA	DATEX-OHMEDA HMEF 500	2002-08-30
PMN K022507 DATEX-OHMEDA	DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02	2002-08-23
PMN K021279 DATEX-OHMEDA	DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE	2002-07-19
PMN K020479 DATEX-OHMEDA	DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES	2002-03-26
PMN K013389 DATEX-OHMEDA	DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES	2002-01-10
PMN K013387 DATEX-OHMEDA	DATEX-OHMEDA S/5 WEB VIEWER	2002-01-08
PMN K012531 DATEX-OHMEDA	DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX	2001-11-02
PMN K012837 DATEX-OHMEDA	MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES	2001-09-14
PMN K001814 DATEX-OHMEDA	DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES	2000-08-23
PMN K000815 DATEX-OHMEDA	AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)	2000-06-08
PMN K000882 DATEX-OHMEDA	DATEX-OHMEDA CS/3 TELEMETRY SYSTEM	2000-06-05
PMN K000168 DATEX-OHMEDA	CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)	2000-04-13
PMN K000186 DATEX-OHMEDA	DATEX-OHMEDA INOVENT DELIVERY SYSTEM	2000-02-10

Similar & Related FDA Registered Companies

• Datex Ohmeda Inc.
• DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C
• Datex-Ohmeda, Inc., A General Electric Companyp.o. Box 7550madison, WI 53707-7550 PMA NumberP210018 Date Received05/03/2021 Decision Date03/17/2022 Product Code QSF  Advisory Committee Anesthesiology Clinical TrialsNCT02972892 Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	SD273	DATEX-OHMEDA
NCAGE Code	S4713	DATEX-OHMEDA
NCAGE Code	FA7E7	DATEX OHMEDA
NCAGE Code	A032G	DATEX-OHMEDA
CAGE Code	A032G	DATEX-OHMEDA
CAGE Code	FA7E7	DATEX OHMEDA
CAGE Code	S4713	DATEX-OHMEDA
CAGE Code	SD273	DATEX-OHMEDA

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019103019039	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	AMSORB PLUS JERICAN, 5.0L	1 PCS
2019101064907	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	AMSORB PLUS JERICAN, 5.0L	1 PCS
2019091142378	Shanghai ,China (Mainland) -> Los Angeles, California	ALUMINIUM DIE-CASTING	8 PKG
2019083041649	Shanghai ,China (Mainland) -> Los Angeles, California	PLASTIC COVER	18 PKG