14 results
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20ms
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Sources: EU EUDAMED, US FDA
REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE
FDA 510(k)
FDA Class 2
·Dental
Bionet
FDA UDI
SUNTECH MEDICAL, INC.·10840935108986·
ZYGOMATIC IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·April 15, 2025
ZYGOMATIC IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·July 21, 2024
ZYGOMATIC IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·April 15, 2025
INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INDIGO LASEROPTIC TREATMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 27, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 14, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008
BIPAP AUTO
FDA Adverse Event
Injury
·RESPIRONICS INC.·Product code BZD·October 21, 2010
MONOFOCAL IOL
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·March 14, 2024
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018