12 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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CERAMIC PEDATRIC PREFORMED CROWN
FDA 510(k)
FDA Class 1
·Dental
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450462683·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450562901·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450473986·
GOLD CORE 73 LS
FDA 510(k)
FDA Class 2
·Dental
KARL STORZ 3D VIDEO SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 9, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 3, 2013
OPTISENSE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 14, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·May 17, 2011
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·February 28, 2018
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