14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
FDA 510(k)
FDA Class 1
·General Hospital
RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
FDA 510(k)
FDA Class 2
·Anesthesiology
Electric wheelchair (Model: S7012)
FDA 510(k)
FDA Class 2
·Physical Medicine
SWANSON
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWH·March 4, 2019
Widex
FDA UDI
Widex A/S·05706069728231·Widex EVOKE E-FS (Tech Black S-440 ) Telecoil, ...
XIVE
FDA Adverse Event
Injury
·DENTSPLY TULSA·Product code DZE·October 15, 2008
INTEGRITY RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MAF·August 5, 2011
LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·July 2, 2013
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·January 3, 2019
GORE VIABAHN ENDOPROSTHESIS - 3
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code PFV·September 6, 2019
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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025