18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALKALINE PHOSPHATASE LIQUID REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040009390·Zirlux 16+ A1 coloring liquid
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033299135·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033299050·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033299098·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033299081·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033299104·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033299111·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033299128·
PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
FDA 510(k)
FDA Class 2
·Hematology
ACTI-FLEX IV ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
CM ALVIM IMPLANT 3.5X13
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·May 3, 2018
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·October 23, 2023
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 19, 2013
SAVINA
FDA Adverse Event
Injury
·DRAEGER MEDICAL GMBH·Product code CBK·March 1, 2011
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018