11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WALLFLEX ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 16, 2025
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SIREMOBIL ISO-C 3D
FDA 510(k)
FDA Class 2
·Radiology
RUSCH POLYFLEX STENT KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SUPRIS SUPRAPUBIC SURGIC
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code OTN·December 19, 2017
SERVICE, CCU, HIGH DEF, 560P, 2NDGEN
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code GCJ·May 9, 2016
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code JDI·April 23, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 9, 2014
VICTORY XL DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·July 11, 2008
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
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024