20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DOSE VOLUME HISTOGRAM (DVH) EVALUATOR
FDA 510(k)
FDA Class 2
·Radiology
IV START PAK W/PERSIST, TEGADERM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·March 3, 2021
ABI VEST AIRWAY CLEARANCE SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS
FDA 510(k)
FDA Class 2
·Radiology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Death
·MEDTRONIC MINIMED·Product code OYC·May 3, 2013
BRYAN CERVICAL DISC SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MJO·September 16, 2014
3F X 60CM SINGLE VASCU-PICC
FDA Adverse Event
Malfunction
·MEDCOMP·Product code LJS·April 15, 2011
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
ROD Ø5.5 SOFT CURV L70 TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 5, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
ROD Ø5.5 SOFT CURV L70 TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·November 10, 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