17 results
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18ms
·
Sources: EU EUDAMED, US FDA
BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
Zirlux
FDA UDI
HENRY SCHEIN, INC.·00304040056356·Zirlux Multi Anterior A3.5,98.5X16
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04047872673174·LEVAMED STABILI-TRI ANK BLU R I
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033381960·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033381953·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033381939·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033381946·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033381922·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033381977·
LIPOPRINT SYSTEM, LDL SUBFRACTIONS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 20, 2013
WASH SET 175E
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code CAC·March 3, 2011
INDURA
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·February 12, 2008
Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013
Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 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