12 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2
FDA 510(k)
FDA Class 2
·Radiology
BD INTIMA-II 22GAX1.00IN PRN SLM NPVC
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·December 24, 2024
MINOLTA PULSOX-2
FDA 510(k)
FDA Class 2
·Cardiovascular
R&D PROJECT DW269#25
FDA 510(k)
FDA Class 2
·Dental
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·April 29, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·April 12, 2011
PATIENT GROUNDING PAD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code ODR·July 25, 2008
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 11, 2019
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