8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CIBA CORNING 248 PH/BLOOD GAS ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Ear and Ulcer Syringe
FDA UDI
C. R. Bard, Inc.·10801741075992·Ear and Ulcer Syringe, 3 oz., with Slim tip, Bulk
PRISMA UNIVERSAL BOND(R) 3
FDA 510(k)
FDA Class 2
·Dental
COMBO FETAL SCALP ELECTRODE/LEGPLATE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 30, 2013
TERUMO CENTRIFUGAL SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWA·December 3, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 15, 2014
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
FDA Enforcement
Class I
·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021