Medical Device Manufacturer · US , Madison , WI

Datex-Ohmeda, Inc. - FDA 510(k) Cleared Devices

61 submissions · 61 cleared · Since 1998

Recent clearances: Giraffe™ OmniBed™ Carestation (CS1), Giraffe OmniBed Carestation (CS1), Carestation 750/750c

61

Total

61

Cleared

0

Denied

FDA 510(k) Regulatory Record - Datex-Ohmeda, Inc. Anesthesiology ✕

45 devices

1-12 of 45

Cleared Mar 28, 2023

Carestation 750/750c

Anesthesiology · 473d

Cleared Nov 04, 2021

Anesthesiology · 268d

Cleared Jan 04, 2018

Tec 820, Tec 850

Anesthesiology · 119d

Cleared Nov 03, 2017

Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100,...

Anesthesiology · 120d

Cleared Aug 15, 2017

Anesthesiology · 145d

Cleared Jan 21, 2016

Carestation 620/650/650C

Anesthesiology · 225d

Cleared Jun 12, 2015

Anesthesiology · 266d

Cleared Apr 24, 2015

Anesthesiology · 133d

Cleared Feb 03, 2015

ENGSTROM CARESTATION, ENGSTROM PRO

Anesthesiology · 334d

Cleared Dec 20, 2013

GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)

Anesthesiology · 130d

Cleared Feb 06, 2013

GE DATEX-OHMEDA AVANCE CS2

Anesthesiology · 125d

Cleared Dec 16, 2011

GE DATEX-OHMEDA AVANCE

Anesthesiology · 88d

Looking for a specific device from Datex-Ohmeda, Inc.? Search by device name or K-number.

Search all Datex-Ohmeda, Inc. devices