17 results
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29ms
·
Sources: EU EUDAMED, US FDA
SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1
FDA 510(k)
FDA Class 1
·Physical Medicine
EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDCOMP ASH SPLIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·July 25, 2018
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·April 2, 2013
AFFINITY BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·March 21, 2011
PLAYTEX, GENTLE GLIDE, REGULAR, NON-DEODORANT, TAMPONS
FDA Adverse Event
Malfunction
·PLAYTEX PRODUCTS, INC.·Product code HEB·January 9, 2008
SYNDEO SYRINGE PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code MEA·October 8, 2009
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016