19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040012901·Zirlux 16+ C4 95X30
CERASMART®
FDA UDI
Gc America Inc.·D0470119531·CERASMART® Glidewell 14 A3.5 HT 5p Block
INSET II
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 27, 2025
INSET II
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 30, 2025
INSET II
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 30, 2025
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
FDA 510(k)
FDA Class 2
·Hematology
PASCO MIC AND MIC/ID PANELS
FDA 510(k)
FDA Class 2
·Microbiology
INSET II
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 30, 2025
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 17, 2025
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 17, 2025
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 30, 2025
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·March 19, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 14, 2011
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 11, 2008
West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.
FDA Enforcement
Class III
·Terminated·Focus Diagnostics Inc·November 7, 2012
West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.
FDA Recall
Terminated
·Focus Diagnostics Inc·Product code NOP·October 3, 2012
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014