19 results · 32ms · Sources: EU EUDAMED, US FDA

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DENFIL

FDA 510(k)
FDA Class 2 ·Dental

GALEMED PEAK FLOW METER, MODELS 3751/3752

FDA 510(k)
FDA Class 2 ·Anesthesiology

MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

VERTEX RECONSTRUCTION SYSTEM

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

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019

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

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 4, 2019

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

QUATTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·April 4, 2013

VITALITY DS VR

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

SAGB QUICK CLOSE

FDA Adverse Event
Injury ·OBTECH MEDICAL SARL_·Product code LTI·April 6, 2011

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