14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
7051395 CANADA INC DBA HTA DIRECT SOURCING
FDA registration
7051395 CANADA INC DBA HTA DIRECT SOURCING·35 products·🇺🇸 United States
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO 30 EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
RING ANNULOPLSTY TRICUSP CONTOUR 3D 26MM
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 10, 2019
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 10, 2013
ILLUMENA-SYR-W/HF-150 ML BX50
FDA Adverse Event
Malfunction
·COVIDIEN·Product code DXT·May 16, 2008
VASCU-GUARD PERIPHERAL VASCULAR PATCH
FDA Adverse Event
Injury
·SYNOVIS SURGICAL INNOVATIONS·Product code DXZ·April 7, 2011
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 10, 2010
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·January 10, 2019
CLEAR PLASTIC EYESHIELD
FDA Adverse Event
Injury
·7051395 CANADA INC DBA HTA DIRECT SOURCING·Product code HOY·March 24, 2025
SYNERGY
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 30, 2014
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