11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2
FDA 510(k)
FDA Class 2
·Radiology
Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code LNH·October 12, 2005
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032490·Baltic Denture System BDLoad Mm6 PLSEbim6DFm C1...
ACE Surgical Pl Gut 5-0 18" Dsm13
FDA UDI
Surgical Specialties México, S. de R.L. de C.V.·00848782022823·003-2490 Pl Gut 5-0 18" Dsm13
ORION DIGITAL IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER
FDA 510(k)
FDA Class 2
·Radiology
PINN MAR LIP LNR 28IDX48OD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·April 3, 2013
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 23, 2011
ALARIS PCA MODULE
FDA Adverse Event
Other
·CARDINAL HEALTH ALARIS PRODUCTS·Product code MEA·April 16, 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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016