21 results
·
22ms
·
Sources: EU EUDAMED, US FDA
CANDELA SMOOTHBEAM LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TKD SCALERS
FDA 510(k)
FDA Class 2
·Dental
ACCU-CHEK INFORM METER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 15, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·September 26, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·July 26, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 11, 2017
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·October 25, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·April 4, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·April 6, 2017
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code FMF·March 28, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·March 4, 2011
INFINITI VISION SYSTEM
FDA Adverse Event
Injury
·ALCON-IRVINE TECHNOLOGY CENTER·Product code HQC·April 17, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 7, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·October 3, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 30, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·May 12, 2016
TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWQ·September 9, 2015
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·May 12, 2016
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