19 results
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34ms
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Sources: EU EUDAMED, US FDA
FOLDING ROLL-ABOUT CHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BEAUTIBOND
FDA 510(k)
FDA Class 2
·Dental
PULSE GEN MODEL 103
FDA Adverse Event
Death
·CYBERONICS, INC.·Product code LYJ·May 9, 2014
UNKNOWN DEPUY ASR ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 24, 2012
PUMP MMT-715LNAS PRDGM INS V2.1 SK EN
FDA Adverse Event
Death
·MEDTRONIC MINIMED·Product code LZG·August 10, 2010
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·April 23, 2018
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 30, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·October 2, 2019
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·December 13, 2019
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 26, 2019
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 18, 2020
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·May 18, 2020
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·June 17, 2020
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 27, 2018
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·August 2, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 1, 2018
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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