21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER
FDA 510(k)
FDA Class 2
·Orthopedic
TRAPSYSTEM SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PERSONA STEMMED NATURAL TIBIA COMPONENT
FDA Adverse Event
Injury
·ZIMMER INC·Product code JWH·May 1, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 16, 2014
FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU
FDA Adverse Event
Other
·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·April 21, 2011
ACTIV.A.C. THERAPY
FDA Adverse Event
Injury
·KCI USA INC.·Product code OMP·June 18, 2015
V.A.C. GRANUFOAM DRESSING
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020
ACTIV.A.C.¿ THERAPY SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·February 12, 2018
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·September 3, 2020
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·September 3, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020
INFOV.A.C. THERAPY SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC·Product code OMP·March 4, 2021
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·May 22, 2020
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