17 results
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29ms
·
Sources: EU EUDAMED, US FDA
THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306
FDA 510(k)
FDA Class 2
·Orthopedic
OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
PRE-LOADED BIOSTINGER HORNET
FDA 510(k)
FDA Class 2
·Orthopedic
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP·Product code DQX·October 27, 2009
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 7, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·July 14, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·November 9, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010
RESOLUTE INTEGRITY RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·March 27, 2013
CL NON-DEHP SOL SET 10 DPM .22FILTER 102" Y@6 W/2PC LL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·March 17, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 27, 2008
TRANSEND GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 27, 2010
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·April 27, 2022
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016