18 results
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20ms
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Sources: EU EUDAMED, US FDA
ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16740914600·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674091460060·
LEONE SPA
FDA UDI
LEONE SPA·08033707065760·INTRAORAL ELASTICS 6,5 oz 3/8" orange
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450845035·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450214589·
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
FDA 510(k)
FDA Class 1
·Microbiology
WUJIN #3 TIBIAL BONE PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 18, 2024
GAS MODULE II
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code BZK·April 30, 2013
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 20, 2014
ALARIS PUMP MODULE
FDA Adverse Event
Injury
·CAREFUSION CORPORATION·Product code FRN·May 4, 2011
BLUNT TIP SCREW, 4X34MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·December 19, 2022
BLUNT TIP SCREW, 4X42MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·December 19, 2022
BLUNT TIP SCREW, 4X38MM
FDA Adverse Event
Injury
·ZIMMERSWITZERLAND MANUFACTURING GMBH·Product code HSB·December 19, 2022
GMK STD CEMENTED FEMUR SIZE 5 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·May 14, 2014
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
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018