11 results
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18ms
·
Sources: EU EUDAMED, US FDA
DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120307631·Diamond, torpedo conical, medium grit
PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051
FDA 510(k)
FDA Class 3
·Cardiovascular
2010 PLUS HOLTER FOR WINDOWS
FDA 510(k)
FDA Class 2
·Cardiovascular
VERTE-STACK K030736, K041197
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019
BD INSYTE AUTOG BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 2, 2024
LIFESCAN
FDA Adverse Event
Injury
·LIFESCAN·Product code NBW·January 27, 2017
GORE VIABAHN ENDOSPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code NIP·March 27, 2013
ENDO STITCH SURGIDAC 2/0 48 GRN DLU SU
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL·Product code KOG·March 22, 2011
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Death
·PHYSIO-CONTROL, INC.·Product code MKJ·April 17, 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