Data / Medical devices / United States / Carestream Medical

Carestream Medical: FDA-registered device maker in Sanford, FL, United States, 3 510(k) clearances

Name: Carestream Medical FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Carestream Medical is registered with the FDA (registration 3010396502) in Sanford, FL, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 30, 2012. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010396502
Address: 1201 Upsala Rd, Sanford, FL, United States, 32771
Owner or operator: CAREstream Medical LTD (10044901)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed: November 20, 2020
Registered through: 2026
Brand names listed: A2M, Active Waste Gas Scavenger, Passive waste gas scavenger model 14600, Pro-Nox, Pro-Vac Blower

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Gas-Scavenging	CBN	2	Manufacturer	accessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Repackager or relabeler	accessdata.fda.gov
Mixer, Breathing Gases, Anesthesia Inhalation	BZR	2	Complaint file establishment	accessdata.fda.gov
Platelet And Plasma Separator For Bone Graft Handling	ORG	2	Repackager or relabeler	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
April 30, 2012	K113687	EQUINOX RELIEVE	BZR	Substantially Equivalent	O-Two Medical Technologies, Inc.	accessdata.fda.gov
June 23, 2011	K110930	ACTIVE WASTE GAS SCAVENGER	CBN	Substantially Equivalent	G. Dundas Co.,Inc.	accessdata.fda.gov
April 14, 2008	K080039	PASSIVE WASTE GAS SCAVENGER, MODEL 14600	CBN	Substantially Equivalent	G. Dundas Co.,Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 15, 2018	80340	Class II	Terminated	CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI	Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.	accessdata.fda.gov

Compare with other makers

Updated April 30, 2012. 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.