10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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3M ESPE LAVA CHAIRSIDE ORAL SCANNER
FDA 510(k)
FDA Class 2
·Dental
LAVA C.O.S. POWDER
FDA Adverse Event
Injury
·3M ESPE DENTAL PRODUCTS·Product code NOF·March 16, 2012
TRIAD II MODULAR TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B
FDA 510(k)
FDA Class 2
·Cardiovascular
LINEAR 3-6
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 13, 2022
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 6, 2023
PROLENE POLYPROPYLENE SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAW·April 23, 2013
LINEAGE(R) DURAMER(R) ACETABULAR LINER
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·April 29, 2011
DURATA STS OPTIM ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 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