10 results · 21ms · Sources: EU EUDAMED, US FDA

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TEPHAFLEX ABSORBABLE SUTURE

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

BD INSYTE¿ IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·March 17, 2020

FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW

FDA 510(k)
FDA Class 2 ·Anesthesiology

CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

IMPLANTABLE NEUROSTIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·April 29, 2013

XPAND CORPECTOMY SPACER SMALL 12X14 3.5/3.5 DEGREE

FDA Adverse Event
Malfunction ·GLOBUS MEDICAL, INC.·Product code MQP·April 29, 2011

ONE TOUCH ULTRA METER

FDA Adverse Event
Injury ·LIFESCAN, INC.·Product code NBW·July 24, 2008

Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

FDA Enforcement
Class II ·Terminated·Trumpf Medical Systems, Inc.·September 12, 2012

Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

FDA Recall
Terminated ·Trumpf Medical Systems, Inc.·Product code FSY·May 29, 2012

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