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ORIDION MEDICAL 1987 LTD.

Last updated May 27, 2026

Information

Country: US
Address: —
Website: covidien.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(508)261-8000
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 600111512

Catalogue (217)

Page 1 of 5

Device	Model / Reference	Registries	Class	Status
Oridion	RS08251	FDA UDI	Class II	Unknown
Microstream	015012	FDA UDI	Class II	Active
Microstream Advance	MVIIH	FDA UDI	Class II	Active
Microstream	PM35MN02	FDA UDI	Class II	Active
Microstream	CS08658-02	FDA UDI	Class II	Unknown
Microstream	PM35MN02-RR	FDA UDI	Class II	Active
Microstream Advance	MVPN	FDA UDI	Class II	Active
Microstream Advance	MVAIHH	FDA UDI	Class II	Active
Microstream	015281_RMS1	FDA UDI	Class II	Unknown
Microstream	015776_RMS1	FDA UDI	Class II	Active
Microstream Advance	MVAIHL	FDA UDI	Class II	Active
Microstream	PM35VAA	FDA UDI	Class II	Active
Microstream	015708_RMS1	FDA UDI	Class II	Active
Surestream	012527_RMS1	FDA UDI	Class II	Unknown
Microstream	CS03743	FDA UDI	Class II	Active
Microstream Advance	MVA	FDA UDI	Class II	Active
Microstream	015510	FDA UDI	Class II	Active
Microstream	PMC40M-GE	FDA UDI	Class II	Active
Microstream Advance	MVINOH	FDA UDI	Class II	Active
Microstream	015307	FDA UDI	Class II	Unknown
Capnostream	011149	FDA UDI	Class II	Active
Microstream	015707_RMS1	FDA UDI	Class II	Active
Microstream Luer	MLPNO	FDA UDI	Class II	Active
Microstream Advance	MVAOH	FDA UDI	Class II	Active
Microstream	CS08652-01	FDA UDI	Class II	Unknown
Oridion	010993	FDA UDI	Class I	Unknown
Microstream Advance	MVAI100U	FDA UDI	Class II	Active
Microstream	CS04934	FDA UDI	Class II	Active
Microstream	015328	FDA UDI	Class II	Active
Microstream Luer	MLA100U	FDA UDI	Class II	Active
Microstream Advance	MVABO	FDA UDI	Class II	Active
Microstream Luer	MLAO	FDA UDI	Class II	Active
CapnoStream	BP01000	FDA UDI	Class II	Active
Microstream	012604_RMS1	FDA UDI	Class II	Active
Microstream	PM35CHG	FDA UDI	Class II	Unknown
Microstream	015311	FDA UDI	Class II	Unknown
Omnistream	011401	FDA UDI	Class I	Active
Microstream	007917	FDA UDI	Class II	Active
Microstream Advance	MVANO100U	FDA UDI	Class II	Active
Microstream Advance	MVPNOH	FDA UDI	Class II	Active
Microstream Advance	MVANOL100U	FDA UDI	Class II	Active
Microstream	007909	FDA UDI	Class II	Active
Microstream Luer	MLABOL	FDA UDI	Class II	Active
Microstream	006324COV-05	FDA UDI	Class II	Active
Microstream Luer	ML	FDA UDI	Class II	Active
Microstream	015771	FDA UDI	Class II	Active
Surestream	012686	FDA UDI	Class II	Active
Microstream Advance	MVAB100U	FDA UDI	Class II	Active
Microstream Advance	MVAOL100U	FDA UDI	Class II	Active
Microstream	015283	FDA UDI	Class II	Unknown

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FDA Recalls (29)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 16, 2012	Z-1333-2012	—	terminated	CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
Feb 16, 2012	Z-1334-2012	—	terminated	CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
Feb 16, 2012	Z-1332-2012	—	terminated	CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
Dec 1, 2011	Z-1347-2012	—	terminated	Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
Dec 1, 2011	Z-1346-2012	—	terminated	Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
Dec 1, 2011	Z-1350-2012	—	terminated	Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
Dec 1, 2011	Z-1349-2012	—	terminated	Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
Dec 1, 2011	Z-1348-2012	—	terminated	Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
Mar 25, 2011	Z-2235-2011	—	terminated	fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient
Mar 25, 2011	Z-2236-2011	—	terminated	fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient
Mar 25, 2011	Z-2233-2011	—	terminated	fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient
Mar 25, 2011	Z-2234-2011	—	terminated	fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient
May 26, 2010	Z-2010-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2013-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2002-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2011-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2003-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2005-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2006-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2012-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2001-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2007-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-1999-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2004-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2014-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2008-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2009-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
May 26, 2010	Z-2000-2010	—	terminated	The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
Jun 30, 2009	Z-2232-2009	—	terminated	1) The monitor's ability to withstand electrostatic discharge (ESD) to exposed metal connectors on the back of the monitor which may cause the monitor's display to freeze. 2) The unit generates electromagnetic radiation above the limits set by applicable standards for medical devices

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Oridion Medical 1987 Ltd. JERUSALEM · IL FEI 3001227743