14 results · 22ms · Sources: EU EUDAMED, US FDA

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CENTRICITY PACS SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0134150·Trial, TLIF, 27L OB STR 7Deg, 15mm

BD 1ML SYRINGE LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 18, 2020

ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE

FDA 510(k)
FDA Class 2 ·Cardiovascular

SYNTHES ANKLE ARTHRODESIS PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

NUVASIVE

FDA Adverse Event
Injury ·NUVASIVE·Product code NKB·January 10, 2011

HEARTSTART MRX-EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 12, 2013

CENTRA BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·March 15, 2011

INSIGNIA ENTRA

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008

FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS

FDA Adverse Event
Injury ·COOK INC·Product code EZN·May 21, 2019

SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

FDA Enforcement
Class II ·Terminated·Unomedical As·November 9, 2016

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

FDA Enforcement
Class II ·Terminated·Unomedical As·July 1, 2015

Cocoon Convective Warming System, Product Code: CWS4000 (110V).

FDA Enforcement
Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

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