Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

65 results for "Datex-Ohmeda, Inc."
1–24 of 65
Search insights Median review: 94d Cleared: 100% Top manufacturer: Datex-Ohmeda, Inc. Lead specialty: Anesthesiology
Cleared Aug 10, 2026
Novii+ Wireless Patch System
K254036 · HGM
Datex-Ohmeda, Inc.
Obstetrics & Gynecology · 237d
Cleared Jul 28, 2026
Giraffe™ OmniBed™ Carestation (CS1)
K260326 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 179d
Cleared Oct 22, 2025
Giraffe OmniBed Carestation (CS1)
K251663 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 145d
Cleared Mar 28, 2023
Carestation 750/750c
K213867 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 473d
Cleared Mar 02, 2022
Giraffe Incubator Carestation CS1
K213553 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 114d
Cleared Mar 02, 2022
Giraffe Omnibed Carestation CS1
K213551 · FMT
Datex-Ohmeda, Inc.
General Hospital · 114d
Cleared Nov 04, 2021
CARESCAPE R860
K210384 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 268d
Cleared Jan 04, 2018
Tec 820, Tec 850
K172702 · CAD
Datex-Ohmeda, Inc.
Anesthesiology · 119d
Cleared Nov 03, 2017
Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100,...
K172045 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 120d
Cleared Aug 15, 2017
Aisys CS2
K170872 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 145d
Cleared Jan 21, 2016
Carestation 620/650/650C
K151570 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 225d
Cleared Dec 31, 2015
Giraffe Incubator Carestation CS1
K152809 · FMZ
Ohmeda Medical, A Division of...
General Hospital · 94d
Cleared Jun 12, 2015
CARESCAPE R860
K142679 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 266d
Cleared Apr 24, 2015
Aespire View
K143530 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 133d
Cleared Feb 03, 2015
ENGSTROM CARESTATION, ENGSTROM PRO
K140575 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 334d
Cleared Dec 20, 2013
GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
K132530 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 130d
Cleared Feb 06, 2013
GE DATEX-OHMEDA AVANCE CS2
K123125 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 125d
Cleared Oct 02, 2012
GIRAFFE AND PANDA WARMERS
K122267 · FMT
Ohmeda Medical, A Division of...
General Hospital · 64d
Cleared Dec 16, 2011
GE DATEX-OHMEDA AVANCE
K112722 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 88d
Cleared Jul 20, 2011
GE DATEX-OHMEDA AISYS
K110213 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 176d
Cleared Jul 21, 2010
GIRAFFE AND PANDA WARMERS
K101804 · FMT
Ohmeda Medical, A Division of...
General Hospital · 23d
Cleared Mar 05, 2009
GE DATEX-OHMEDA AISYS
K090233 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 34d
Cleared Oct 03, 2008
ENGSTROM CARESTATION, ENGSTROM PRO
K081842 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 95d
Cleared Aug 29, 2008
GE DATEX-OHMEDA AVANCE
K081844 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 60d