12 results
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19ms
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Sources: EU EUDAMED, US FDA
MEDRAD CONTINUUM MR INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032771·Baltic Denture System BDLoad ↓ Sm6 PLSEum6DFs A...
TWIN FIX
FDA 510(k)
FDA Class 2
·Orthopedic
TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BILATERAL DOUBLE BALLOON SET
FDA Adverse Event
Malfunction
·PAJUNK GMBH MEDIZINTECHNOLOGIE·Product code KOG·December 7, 2006
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code DQX·December 18, 2024
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 29, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·March 29, 2011
CRYSTALENS
FDA Adverse Event
Injury
·EYEONICS, INC.·Product code HQL·April 23, 2008
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
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024