12 results
·
25ms
·
Sources: EU EUDAMED, US FDA
VASCUTRAK II PTA DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
THREADED ROD
FDA UDI
Biomet Orthopedics, LLC·00887868005848·
MODIFICATION TO FLOUROLAB PLUS
FDA 510(k)
FDA Class 2
·Neurology
SELF SEAL STERILIZATION POUCH
FDA 510(k)
FDA Class 2
·General Hospital
HAWKONE
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MCW·July 10, 2015
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 27, 2021
SILCONE COATED I/A 45 HANDHELD INSTRUMENT
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQC·May 7, 2019
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 8, 2013
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 29, 2011
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
HAWKONE
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MCW·July 10, 2015
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