11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818087020268·Steerable Duo-Decapolar Catheter, Multi-Purpose...
ASNIS
FDA UDI
Stryker GmbH·04546540373069·Tray Insert
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
ARTHROCARE COBLATOR IQ SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RCSP RETROGRADE CANNULA
FDA Adverse Event
Injury
·MEDTRONIC PERFUSION SYSTEMS·Product code DWF·November 13, 2013
ENDO GIA II 45-3.5 DLU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC·Product code GCJ·January 2, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·November 17, 2010
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON-IRVINE TECH CTR·Product code HQC·May 7, 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
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 2019