19 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS
FDA 510(k)
FDA Class 2
·Neurology
BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)
FDA 510(k)
FDA Unclassified
·Unknown
ALLOFIT ACETABULAR SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
QUADRA BROACH SIZE 0
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL, SA·Product code JDI·September 7, 2012
BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·November 18, 2019
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·April 29, 2013
9600+
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 29, 2008
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·May 10, 2011
VERCISE GENUS¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·October 21, 2021
ALLOFT-S ALLOCLASSIC SHL 52/II
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code JDI·March 12, 2019
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·July 11, 2019
LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 28 / C
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2020
ALLOFIT-S ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 52/II
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·September 27, 2018
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 25, 2019
LINER: MPACT FLAT PE HC LINER 36/ER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 17, 2020
MPACT LINER FLAT PE HC LINER Ø 32/D
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·January 5, 2016
CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·February 17, 2022
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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