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

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ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY

FDA 510(k)
FDA Class 2 ·Immunology

AIMSTEP PREGNANCY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/ DUAL PORT

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 9, 2018

BD NEXIVA CLOSED IV CATHETER SYSTEM W/ DUAL PORT

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 31, 2018

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 3, 2013

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code DQX·March 28, 2011

PUMP MMT-722NAS PRDGM INS V2.2 SK EN

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code LZG·April 16, 2008

11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code HSB·February 11, 2016

1710034-2018-00691

FDA Adverse Event
Malfunction ·October 9, 2018

BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/ DUAL PORT

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 7, 2018

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

The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016