12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ALEUTIAN IBF SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NIVO Nebulizer System
FDA UDI
AEROGEN LIMITED·05391517933574·NIVO Pro-X Controller Kit -JAPAN
TRIO LX SMALL CONNECTOR
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011
SCOOTER MARS SERIES, MODEL TL-588
FDA 510(k)
FDA Class 2
·Physical Medicine
VANGUARD REPROCESSED PHACOEMULSIFICATION
FDA 510(k)
FDA Class 2
·Ophthalmic
GRAFTYS HBS (510K NUMBER: K082498)
FDA Adverse Event
Injury
·GRAFTYS·Product code MQV·July 11, 2013
QUADRA-H CEMENTLESS, HA COATED STEM SIZE 6 LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·November 24, 2016
M-1 COT - BASE HIGH LOAD 28
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 29, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·April 28, 2011
VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM
FDA Adverse Event
Malfunction
·EDWRDS LIFESCIENCES·Product code DQO·July 21, 2008
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