14 results
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19ms
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Sources: EU EUDAMED, US FDA
RELAXOR PERFECT TOUCH AIR MASSAGING SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776380281·RANKIN RAGNELL RETRACTOR, CUSTOM 30 x 5mm Long ...
Latitude
FDA UDI
TORNIER, INC.·00840338602251·Humeral Tray
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5820304370·RETRACTOR, ALL TYPES
RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE
FDA 510(k)
FDA Class 3
·Cardiovascular
INTERVENTIONAL BODY COIL
FDA 510(k)
FDA Class 2
·Radiology
ODYSSEY LX, MODEL 211320
FDA 510(k)
FDA Class 2
·Radiology
THERMOFLO FILTER PORT
FDA Adverse Event
Injury
·PHARMA SYSTEMS·Product code BYD·February 12, 2010
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 2, 2013
ANALYTICAL P MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 17, 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
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