13 results · 21ms · Sources: EU EUDAMED, 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