12 results
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20ms
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Sources: EU EUDAMED, US FDA
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Thermaloy
FDA UDI
Rmo, Inc.·00885797017321·THERMALOY(R) PREFORMED NATURAL ARCH MX .016 X .022
PLEXOLONG SETS
FDA 510(k)
FDA Class 2
·Anesthesiology
ULTRASOUND SCANNER TYPE 2101
FDA 510(k)
FDA Class 2
·Radiology
PLASTIPAK LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 23, 2025
PLASTIPAK LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 23, 2025
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 8, 2013
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·April 21, 2011
DURATA STS OPTIM ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 1, 2016
STARCLOSE SE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·March 24, 2025
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