14 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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EAR MUFFINS
FDA 510(k)
FDA Class 2
·Neurology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04047872673167·LEVAMED STABILI-TRI ANK SUP BLU L IV
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890123840·Zirlux Shading Liquid - Dentin, A4, 100ml
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033397985·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033397992·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033398005·
K012364
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 3, 2015
M-XX OXYGEN SENSORS
FDA 510(k)
FDA Class 2
·Anesthesiology
HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883
FDA 510(k)
FDA Class 2
·Microbiology
DESARA
FDA Adverse Event
Injury
·CALDERA MEDICAL, INC.·Product code FTL·March 7, 2013
ADVIA CENTAUR HBC TOTAL(HBCT)
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LOM·March 9, 2011
VECTRA GENISYS LASER
FDA Adverse Event
Other
·CHATTANOOGA GROUP·Product code GEX·March 7, 2008
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
Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·January 24, 2018