16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIGHTSPEED 4.0 CT SCANNER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Smith & Nephew, Inc.·23596010091134·BONE TUNNEL PLUG NON-CANNULATED,
...
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033508718·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033508701·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033508695·
VERDICT -II BAR/BZO
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INVACARE PASSOVER HUMIDIFIER MODEL ISP9700
FDA 510(k)
FDA Class 2
·Anesthesiology
OSSEOTITE® CERTAIN® IMPLANT 3.25 X 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 2, 2022
VALIANT THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·March 20, 2013
APEXPRO TELEMETRY SYSTEM
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MHX·February 3, 2011
GEM III AT
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·March 10, 2008
SHELL POROUS WITH CLUSTER HOLES
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code LPH·May 26, 2017
ARROW PICC COMPONENT: 3 FR X 21-1/2" (55 CM)
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code LJS·December 4, 2020
ARROW PI PICC KIT: 2L 5.5FR 55CM AGBA TIPT
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code LJS·November 15, 2023
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