11 results
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20ms
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Sources: EU EUDAMED, US FDA
DYNATRON IBOX IONTOPHORESIS DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306836183·William Lacrimal Duct Probe, 7-8"
FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AMBULATORY ENTERAL NUTRITION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 21, 2025
GRAFTON PLUS¿ DBM
FDA Adverse Event
Malfunction
·Product code NUN·August 28, 2020
GRAFTON PLUS¿ DBM
FDA Adverse Event
Malfunction
·Product code NUN·August 28, 2020
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 9, 2013
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 25, 2011
LD CV EZTRK 2 BP IS1 4543 90CM US
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWP·May 8, 2008
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