11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BGM GALECTIN -3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450584002·
BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)
FDA 510(k)
FDA Unclassified
·Unknown
ALLOFIT ACETABULAR SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
NV MICROCATHETER
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·July 9, 2020
ALLOFT-S ALLOCLASSIC SHL 52/II
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code JDI·March 12, 2019
VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code MAF·May 18, 2011
SHILEY
FDA Adverse Event
Injury
·COVIDIEN·Product code JOH·April 30, 2013
CPS/OSS 5CM TPR ADAPT W/OSS SC
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KRO·September 16, 2014
ALLOFIT-S ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 52/II
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·September 27, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012