11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FORESEE HOME
FDA 510(k)
FDA Class 1
·Ophthalmic
IMPULSE SELECT
FDA 510(k)
FDA Class 2
·Anesthesiology
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 4, 2023
UNKNOWN MICROCATHETER
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code NVY·January 13, 2014
11.0MM TI HELICAL BLADE 115MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·May 3, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 6, 2011
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·December 17, 2021
QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·May 19, 2016
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