10 results
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20ms
·
Sources: EU EUDAMED, US FDA
TRU FLU, MODEL 751230
FDA 510(k)
FDA Class 2
·Microbiology
DS DS I-SERIES
FDA 510(k)
FDA Class 2
·Radiology
GSIBP BLOOD PRESSURE CUFF
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 17, 2026
INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 0° ANGLE FOR PIP ARTHROD
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS-SELZACH·Product code HTY·May 3, 2013
CER BIOLOXD OPTION HD 36MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·September 16, 2014
SCREWS & WASHERS, 14MM
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MBI·May 3, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015