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MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

SureSigns VSi

FDA UDI
Philips Medical Systems Hsg·00884838028364·SureSigns VSi - NBP

KPP PERITONEAL DIALYSATE FILTER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07)

FDA 510(k)
FDA Class 2 ·Orthopedic

CONSULTA CRT-D

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014

CAREASSIST BED

FDA Adverse Event
Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·November 1, 2012

ICHEM VELOCITY STRIP

FDA Adverse Event
Malfunction ·IRIS INTERNATIONAL·Product code KQO·June 18, 2015

Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.

FDA Enforcement
Class III ·Terminated·Philips Electronics North America Corporation·December 27, 2017

Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. The SureSigns VSi vital signs monitor is for measurement of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility

FDA Enforcement
Class II ·Terminated·Philips Healthcare Inc.·September 5, 2012

Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. The SureSigns VSi vital signs monitor is for measurement of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility

FDA Recall
Terminated ·Philips Healthcare Inc.·Product code DXN·August 15, 2012