12 results
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29ms
·
Sources: EU EUDAMED, US FDA
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
YALE NH TT VISION SYS GBS
FDA Adverse Event
Other
·GISH BIOMEDICAL, INC.·Product code OEZ·December 3, 2010
DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODIFICATION TO MIRAGE
FDA 510(k)
FDA Class 2
·Radiology
BD ULTRA FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMI·November 7, 2018
VERTE-STACK K030736, K041197
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019
BD ULTRA FINE¿ PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 12, 2019
6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·April 2, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 22, 2011
THERMACHOICE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code MKN·April 17, 2008
PEN NDL 32G 4MM 100BX 1200 USA
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FRN·November 4, 2020
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