13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GE LOGIQ TWIN
FDA 510(k)
FDA Class 2
·Radiology
ISOLA
FDA UDI
DEPUY SPINE, LLC·10705034004808·ISOLA SPINE SYSTEM TRANSVERSE PROCESS STARTER
PULSE
FDA UDI
Nuvasive, Inc.·00887517988041·PULSE II Flat Array, C
BD
FDA UDI
PRYOR PRODUCTS·00761887000285·6 leg IV stand
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450141045·
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA
FDA 510(k)
FDA Class 2
·Cardiovascular
PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
FDA 510(k)
FDA Class 2
·Ophthalmic
AFX
FDA Adverse Event
Malfunction
·ENDOLOGIX, INC.·Product code MIH·August 14, 2015
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 10, 2013
ALCON LABORATORIES
FDA Adverse Event
Malfunction
·ALCON LABORATORIES, INC.·Product code MFK·May 22, 2008
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·April 5, 2011
Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014
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