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

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AUTO THERM 390, MODEL ME 390

FDA 510(k)
FDA Class 2 ·Physical Medicine

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040048689·Curette Gracey DE 11/12

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809869385·FOR MEN 20-30 MM HG THIGH MICRO DOT BAND OPEN T...

KINETRA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 6, 2015

MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

REMSTAR AUTO CPAP SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·November 2, 2010

AISYS

FDA Adverse Event
Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 18, 2016

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·January 5, 2009

VERTEX RECONSTRUCTION SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·July 23, 2010

AISYS

FDA Adverse Event
Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·April 2, 2010

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·November 20, 2009

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 9, 2013

BLAKE DRAIN

FDA Adverse Event
Malfunction ·NI·Product code KOG·April 6, 2011

RAPIDO ADVANCE GUIDE CATHETER

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

Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

FDA Enforcement
Class I ·Terminated·GE Healthcare, LLC·July 17, 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