14 results
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20ms
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Sources: EU EUDAMED, US FDA
PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER
FDA 510(k)
FDA Class 1
·Dental
Safco Shotgum Needles
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310236623·Safco Shotgum needles 30g x-short 100/box
HairCheck-DT (Cocaine)
FDA UDI
Quest Diagnostics·00868586000209·HairCheck-DT (Cocaine) is an ELISA test kit use...
SPINE WORKS COLLAR
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GEM SPLT SET Y-EXT BCXCHK 282CM (50EA/CS)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 6, 2014
GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 6, 2014
GEM SPLT SET Y-EXT BCKCHK 282CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 23, 2014
GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·November 27, 2013
EXETER V40 STEM 35.5MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·March 27, 2013
ACCURUS 800CS
FDA Adverse Event
Other
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 3, 2011
CELL-DYN WBC REAGENT A
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·April 1, 2008
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 19, 2018
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