10 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507
FDA 510(k)
FDA Class 2
·Orthopedic
BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)
FDA 510(k)
FDA Class 2
·Cardiovascular
GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
FDA 510(k)
FDA Unclassified
·Unknown
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 3, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 2, 2014
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 13, 2011
OXYSURE
FDA Adverse Event
Injury
·OXYSURE·Product code CAW·March 19, 2014
SEE H10
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDG·June 4, 2018
OXYSURE
FDA Adverse Event
Injury
·OXYSURE·Product code DQA·March 19, 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