12 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NOBELREPLACE TAPERED CONICAL CONNECTION
FDA 510(k)
FDA Class 2
·Dental
POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN CONTENT LABELING (50 MICRO
FDA 510(k)
FDA Class 1
·General Hospital
LUMALITE CURE LIGHT, MODEL 2100
FDA 510(k)
FDA Class 2
·Dental
LUMA ARCH
FDA Adverse Event
Injury
·LUMALITE, INC.·Product code EEG·July 6, 2004
BD¿ NEEDLE 22X1-1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 15, 2022
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 16, 2013
TRIATHLON-CR FEMORAL COMPONENT CEMENTED #4 LEFT
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·April 7, 2011
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code LWR·June 17, 2008
BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER 24 G X 0.56 IN.
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 23, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018