11 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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NeoWave Pain Relief and Recovery System, Model# T16-2020
FDA 510(k)
FDA Class 2
·Physical Medicine
INSTANT-VIEW TCA URINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)
FDA 510(k)
FDA Class 1
·Dental
REVERSE #SHORT HUM. BODY 140°
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code MBF·November 11, 2022
GLENOSPHERE INSERTER TIP
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 3015516266·Product code LXH·March 12, 2024
GLENOSPHERE INSERTER TIP
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 3015516266·Product code LXH·November 28, 2023
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 11, 2011
ARTEGRAFT
FDA Adverse Event
Malfunction
·ARTEGRAFT, INC.·Product code LXA·July 17, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013
IMPACTOR HANDLE
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 3015516266·Product code LXH·November 28, 2023
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