9 results
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20ms
·
Sources: EU EUDAMED, US FDA
PEDIATRIC ILLUMINATING URETERAL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
1077 EARTIP 8-11 TRANS 250 PCS
FDA UDI
PATH medical GmbH·04260223141270·
MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
FDA 510(k)
FDA Class 2
·Cardiovascular
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DC PLUM W/SEC CONVPN(48/CASE)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 17, 2014
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·CARROLL HEALTHCARE·Product code FNL·November 14, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·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