9 results
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18ms
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Sources: EU EUDAMED, US FDA
WEINSTEIN STYLE INSTRUMENT HOLDER
FDA 510(k)Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818087020442·Fixed, 4 electrode, MPB, 2mm electrode spacing
K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Immunology
GENX CODA AIR PURIFICATION SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
HUDSON SHERIDAN/HVT TRACHEAL TUBE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·January 3, 2013
TPS MICRO DRIVER
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·November 8, 2010
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