13 results
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18ms
·
Sources: EU EUDAMED, US FDA
MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
FDA 510(k)
FDA Class 2
·Anesthesiology
MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JEY·March 3, 2017
PROFILE BIABUT 4.0 -Ø5.5
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·February 24, 2026
TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code DZL·September 6, 2017
COULTER® LH780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·April 11, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 13, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·May 22, 2008
ARTERIAL CANNULA 20G/45MM
FDA Adverse Event
Malfunction
·Product code FOZ·July 15, 2021
TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JEY·March 3, 2017
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
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018