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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MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION
FDA 510(k)
FDA Class 2
·Radiology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809848106·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE EXTRA LA...
LACTOSORB PUSH SCREW
FDA 510(k)
FDA Class 2
·Dental
MUCOGRAFT
FDA 510(k)
FDA Class 2
·Dental
TI PANGEA LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code NKB·June 5, 2012
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 11, 2013
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·March 16, 2011
PROGRAMMING WAND
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 21, 2008
TI PANGEA LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code NKB·June 5, 2012
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
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025