Data / Medical devices / Israel / Baxter Healthcare - Aviv

Baxter Healthcare - Aviv: FDA-registered device maker in Tel Aviv, Israel, 4 510(k) clearances

Name: Baxter Healthcare - Aviv FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Baxter Healthcare - Aviv is registered with the FDA (registration 3005004021) in Tel Aviv, Israel. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 25, 2011. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3005004021
Address: 2A Hashlosha St. F-32, Tel Aviv, Israel, 6706055
Owner or operator: BAXTER HEALTHCARE CORPORATION (1417572)
Roles: Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed: November 16, 2022
Registered through: 2027
Brand names listed: Baxter Starling Sensor, Cheetah Nicom, Cheetah Nicom Reliant, Cheetah Nicom System, Cheetah Nicom with NIBP Functionality, Cheetah Nicom with NIBP and SpO2, Cheetah Reliant, Cheetah Sensors and more

Devices it lists

Device	Product code	Class	Role	Source
Blood Pressure Cuff	DXQ	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-Function	DXG	2	Exporter to the US, Manufacturer, Specification developer	accessdata.fda.gov
Oximeter	DQA	2	Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Oximeter, Ear	DPZ	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Plethysmograph, Impedance	DSB	2	Complaint file establishment, Exporter to the US, Manufacturer, Specification developer	accessdata.fda.gov
Plinth	INT	1	Complaint file establishment, Exporter to the US, Manufacturer, Specification developer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Complaint file establishment, Exporter to the US, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 25, 2011	K103166	CHEETAH RELIANT	DSB	Substantially Equivalent	Cheetah Medical, Inc.	accessdata.fda.gov
July 2, 2010	K101487	CHEETAH NICOM SYSTEM	DXG	Substantially Equivalent	Cheetah Medical, Inc.	accessdata.fda.gov
September 9, 2005	K051904	ALL PURPOSE CUFF, MODEL 222APC	DXQ	Substantially Equivalent	Suntech Medical, Inc.	accessdata.fda.gov
March 7, 2002	K012891	OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)	DQA	Substantially Equivalent	Nellcor Puritan Bennett, Inc.	accessdata.fda.gov

Compare with other makers

Updated January 25, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.