13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
STEAM PAK MOIST HEAT
FDA 510(k)
FDA Class 1
·Physical Medicine
1077 EARTIP 6-9MM BLUE 250 PCS
FDA UDI
PATH medical GmbH·04260223141232·
DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK
FDA 510(k)
FDA Class 2
·Cardiovascular
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·December 9, 2016
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·December 30, 2016
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·December 29, 2016
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 4, 2017
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 27, 2014
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVAMEX·Product code FSA·November 14, 2012
COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 13, 2010
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014