21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LEGEND ALL-POLY CUP
FDA 510(k)
FDA Class 2
·Orthopedic
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0154071·TRIAL, DRILL GUIDE 14 X 11, 7 MM TA
Acapella One
FDA UDI
Choice Spine, LP·00840996150705·ACAPELLA,TRIAL,LR,NS,12X14X7
LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO
FDA 510(k)
FDA Class 1
·General Hospital
SURGITRON IEC II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 4, 2025
CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·April 10, 2013
MOBILE TREAT. REC. LY5007
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FRK·April 4, 2011
ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)
FDA Adverse Event
Malfunction
·COVIDIEN·Product code DXT·May 16, 2008
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 26, 2011
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 30, 2013
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·April 14, 2015
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·May 7, 2010
ARCHITECT ANTI-TPO
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·September 11, 2025
ALINITY I ANTI-TPO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·December 10, 2025
ALINITY I ANTI-TPO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·December 10, 2025
ALINITY I ANTI-TPO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·September 16, 2025
ARCHITECT ANTI-TPO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JZO·May 23, 2025
ALINITY I ANTI-TPO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·March 17, 2025
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