10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Safco FG Diamonds
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310218523·FG Diamond 885-012 beveled cylinder regular ss ...
PORTUX CAD/CAM Disc. 98.5X18mm B1. ML
FDA UDI
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A·07701126710134·PORTUX CAD/CAM Disc. 98.5X18mm B1. ML
DIMENSION HAIC ASSAY, MODEL DF105
FDA 510(k)
FDA Class 2
·Hematology
PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 26, 2013
1.8X13MM MDI STANDARD O-BALL AND COLLAR
FDA Adverse Event
Other
·3M ESPE DENTAL PRODUCTS·Product code DZE·March 8, 2011
INSUFFLATION/ACCESS NEEDLE 14 GAUGE
FDA Adverse Event
Malfunction
·PONCE-USS·Product code GCJ·March 28, 2008
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014