15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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