12 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
HairCheck-DT (Cocaine)
FDA UDI
Quest Diagnostics·00868586000209·HairCheck-DT (Cocaine) is an ELISA test kit use...
WALLFLEX ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 16, 2025
DEVILBISS HUMIDIFIER
FDA 510(k)
FDA Class 2
·Anesthesiology
AML HAIRCHECK-DT (COCAINE)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SYNREAM FLEXSHAFT
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTO·December 4, 2019
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 23, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEM, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 13, 2011
DAMON COPPER NITI WIRE
FDA Adverse Event
Malfunction
·ORMCO CORPORATION·Product code DZC·July 11, 2008
INNOVANCE D-DIMER
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code DAP·July 14, 2017
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
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018