9 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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SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRIO LX SMALL CONNECTOR
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011
INTEX SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS
FDA 510(k)
FDA Class 2
·Dental
LCS COMP RP INSERT STD 12.5MM
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM·Product code NJL·April 17, 2013
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·June 17, 2008
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
FDA Adverse Event
Other
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·April 6, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015