11 results
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23ms
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Sources: EU EUDAMED, US FDA
ARTELON SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 29, 2022
VISION 9000 PHASED ARRAY TORSO COIL
FDA 510(k)
FDA Class 2
·Radiology
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INNOVA 4100
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS·Product code MQB·April 4, 2011
INNOVA 4100
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS·Product code MQB·May 6, 2011
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·September 3, 2010
PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 11, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE·Product code ITI·March 15, 2011
COULTER ACT DIFF ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·May 22, 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