19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION
FDA 510(k)
FDA Class 2
·Radiology
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 16, 2006
SYRINGE 10ML REG PR SALINE 10ML FILL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·November 16, 2023
WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA
FDA 510(k)
FDA Class 2
·Immunology
HANDPIECE SHEATH-MODEL #A910
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 26, 2006
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 26, 2006
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 27, 2006
SYRINGE 10ML REG PR SALINE 10ML FILL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·November 16, 2023
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 31, 2023
CLINITEK ADVANTUS
FDA Adverse Event
Other
·SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS·Product code CDM·March 25, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 28, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 17, 2008
TRIATHLON #4 PS INSERT 11MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·August 23, 2013
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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