9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
USE OF TWEEN 80 AS A WETTING AGENT ON
FDA 510(k)
FDA Class 2
·Cardiovascular
1077 EARTIP 6-9MM BLUE 50 PCS
FDA UDI
PATH medical GmbH·04260223141225·
MOTEX POWDERED NITRILE SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SWINFORD·Product code KDI·May 27, 2014
COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·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