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