16 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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DIGITAL RADIOGRAPHY MODEL CXDI-55G
FDA 510(k)
FDA Class 2
·Radiology
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16740914350·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674091435060·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450220474·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450021606·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450090046·
VIKING OPTIMA GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NDN·March 28, 2013
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NDN·February 27, 2013
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NDN·March 1, 2013
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NDN·February 27, 2013
DPM 6/7 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 16, 2014
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·May 5, 2011
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