14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FIRMM
FDA 510(k)
FDA Class 2
·Radiology
Power Pin
FDA UDI
TP ORTHODONTICS INC·00192029028087·Tooth Colored
Power Pin
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746056314·LONG LEG POWER PIN 50/PKG
AQUACEL FOAM
FDA Adverse Event
Malfunction
·CONVATEC LTD·Product code NAC·December 29, 2023
AQUACEL FOAM
FDA Adverse Event
Malfunction
·CONVATEC LTD·Product code NAC·December 29, 2023
POWDER FREE STERILE LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MILLENNIUM 5000 MEUROVASCULAR COIL
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 24, 2015
ENDURANT ABDOMINAL STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·July 29, 2011
ENTERAL SAFE FEEDING TUBE, 5 FR X 36" POLYURET
FDA Adverse Event
Malfunction
·DEROYAL INDUSTRIES·Product code FPD·September 16, 2014
TI NUT 11MM WIDTH ACROSS FLATS
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWQ·July 2, 2013
BD PHASEAL¿ PROTECTOR P55
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code ONB·March 23, 2023
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 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