9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank
FDA 510(k)
FDA Class 2
·Dental
GOLD CORE PLUS
FDA 510(k)
FDA Class 2
·Dental
REMVIEW SLEEP RECORDER, MODEL 320
FDA 510(k)
FDA Class 2
·Neurology
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GEI·October 17, 2008
CARELINK
FDA Adverse Event
Malfunction
·PLEXUS MANUFACTURING SDN. BHD·Product code KRG·August 11, 2011
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·July 2, 2013
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021