11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPIRIT 300
FDA 510(k)
FDA Class 2
·Anesthesiology
BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
FDA 510(k)
FDA Class 2
·Anesthesiology
32MM M2A MODULAR HEAD -3MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWY·May 5, 2013
RADICAL-7 HANDHELD
FDA Adverse Event
MASIMO CORPORATION·Product code DQA·September 5, 2014
PERFORMA ANGIOGRAPHIC CATHETERS
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·April 14, 2011
BD VACUTAINER® K3E PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·August 3, 2023
ZIMMER M/L TAPER FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LZO·February 17, 2016
KINECTIV MODULAR NECK
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWA·May 26, 2016
MULTIPLE-SEE ATTACHED
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code OAD·March 24, 2009
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