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."
25–48 of 65
Search insights Median review: 94d Cleared: 100% Top manufacturer: Datex-Ohmeda, Inc. Lead specialty: Anesthesiology
Cleared Jan 30, 2008
GE DATEX-OHMEDA AISYS
K073707 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 30d
Cleared Oct 03, 2007
MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA...
K072512 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 27d
Cleared Dec 08, 2006
GE DATEX-OHMEDA ENGSTROM CARESTATION
K062710 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 88d
Cleared Jun 27, 2006
GE DATEX-OHMEDA AISYS
K061609 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 18d
Cleared Jun 05, 2006
GE DATEX-OHMEDA ENGSTROM CARESTATION
K060862 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 68d
Cleared Sep 27, 2005
GE DATEX-OHMEDA ENGSTROM CARESTATION
K051895 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 76d
Cleared Jun 21, 2005
GE DATEX-OHMEDA CENTIVA/5 VENTILATOR
K050860 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 77d
Cleared Apr 12, 2005
GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
K050676 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 27d
Cleared Mar 25, 2005
GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM
K050626 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 14d
Cleared Mar 25, 2005
GE DATEX-OHMEDA ENGSTROM CARESTATION
K050597 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 16d
Cleared Mar 01, 2005
MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER
K043120 · CAH
Datex-Ohmeda, Inc.
General Hospital · 109d
Cleared Feb 04, 2005
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
K050055 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 24d
Cleared Oct 26, 2004
GE DATEX-OHMEDA ENGSTROM CARESTATION
K041775 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 117d
Cleared Sep 20, 2004
GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM
K041524 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 104d
Cleared Sep 02, 2004
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
K040831 · DPZ
Datex-Ohmeda, Inc.
Anesthesiology · 155d
Cleared Aug 31, 2004
GE DATEX-OHMEDA AISYS CARESTATION
K042154 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 21d
Cleared Apr 22, 2004
MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
K040743 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 30d
Cleared Dec 04, 2003
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR
K031124 · MHX
Datex-Ohmeda, Inc.
Cardiovascular · 240d
Cleared Oct 07, 2003
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
K023366 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 364d
Cleared Jun 26, 2003
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)
K031027 · CAD
Datex-Ohmeda, Inc.
Anesthesiology · 86d
Cleared Jun 06, 2003
AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL...
K031479 · DXN
Datex-Ohmeda, Inc.
Cardiovascular · 29d
Cleared Oct 08, 2002
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES...
K021955 · DQA
Datex-Ohmeda, Inc.
Anesthesiology · 116d
Cleared Jan 30, 2002
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER
K012924 · CAD
Datex-Ohmeda, Inc.
Anesthesiology · 152d
Cleared Mar 15, 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
K010463 · DQA
Datex-Ohmeda, Inc.
Anesthesiology · 27d