9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex SwiveLock Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)
FDA 510(k)
FDA Class 2
·Cardiovascular
ANCURE LLIAC BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BD LOGIC BLOOD GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORPORATION·Product code NBW·October 17, 2008
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
UNKNOWN LEAD
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·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