10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SONOLINE G60 S ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EPICOR MEDICAL ABLATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDIPRIME
FDA 510(k)
FDA Class 2
·Radiology
SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·November 4, 2020
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 2, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 13, 2011
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE
FDA Adverse Event
Malfunction
·STAAR SURGICAL·Product code HQL·May 22, 2008
SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 30, 2020
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