10 results
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20ms
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Sources: EU EUDAMED, US FDA
E3-80 PORTABLE ECG RECORDER & ANALYZER
FDA 510(k)
FDA Class 2
·Cardiovascular
GUIDEWIRE INTRODUCER SAFETY NEEDLE
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION? MONTAGE? MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 30, 2025
HEARTSTART ADULT MULTIFUNCTION PADS PLUS
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 8, 2013
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 27, 2011
LASIK
FDA Adverse Event
Injury
·Product code LZS·July 7, 2008
NIBP CUFFS
FDA Adverse Event
Injury
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code OED·August 8, 2025
STERRAD 100NX STERILIZER 1-DR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·January 6, 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