10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OptoMonitor 3
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·August 28, 2020
LINER FOR METAL BACK GLENOID STANDARD
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·December 22, 2021
CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050
FDA 510(k)
FDA Unclassified
·Unknown
WHEELCHAIR, MECHANICAL SERIES MODEL 3100
FDA 510(k)
FDA Class 1
·Physical Medicine
1.5MM TI MATRIXRIB STRAIGHT PL 24 HOLES/240MM LENGTH
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code HRS·September 29, 2014
AUTOMATED PD SET W/CASSETTE 4 PRONG
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code FKX·October 16, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
COULTER® ACT DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 2, 2013
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