9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Overlapped Compression Therapy
FDA 510(k)
FDA Class 2
·Cardiovascular
FOTONA DUALIS PLUS ND:YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
END EXPIRATORY FILTER, MODEL RT020
FDA 510(k)
FDA Class 2
·Anesthesiology
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH LTD./HUNTINGTON·Product code MFK·October 17, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·August 11, 2011
RELIANCE VISION MULTI CHAMBER WASHER
FDA Adverse Event
STERIS CANADA CORPORATION·Product code MEC·July 2, 2013
LAMINAR
FDA Adverse Event
Malfunction
·FLEXTRONICS MEDICAL·Product code HQC·November 21, 2022
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