31 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)
FDA 510(k)
FDA Class 1
·General Hospital
CosmoLock
FDA UDI
Kalitec Direct LLC·B073DRK0100280·Tab Breaker, Single Sided, Cosmolock MIS
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100080·Dilator Sleeve, Probe
Intess C
FDA UDI
Kalitec Direct LLC·B07309K0100280·Caddie Lid, Cervical Implants, Hinged
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100180·SNII Tap, 6.50mm
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0100280·Caddie, 32-36mm Curved Cages
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K0100080·Caddie Lid, Implants and Instruments
Cosmolock
FDA UDI
Kalitec Direct LLC·B07310K0100280·Caddie, MIS Rods and Caps
ADVIA CENTAUR CP TROPONIN ULTRA (TNI ULTRA)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·February 6, 2014
ADVIA CENTAUR CP TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·February 5, 2014
ADVIA CENTAUR XP TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·February 14, 2014
JETLITE 4000
FDA 510(k)
FDA Class 2
·Dental
SULZER ORTHOPEDICS MS-30 FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
ADVIA CENTAUR CP TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·April 2, 2014
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 13, 2025
CEEON
FDA Adverse Event
Injury
·PHARMACIA & UPJOHN, GRONINGEN·Product code HQL·November 5, 2001
CEEON
FDA Adverse Event
Injury
·PHARMACIA & UPJOHN, GRONINGEN·Product code HQL·November 5, 2001
ADVIA CENTAUR XP TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·February 13, 2014
AXSYM DIGOXIN III
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013