12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Z-SERIES MODULAR TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032729·Baltic Denture System BDLoad ↓ Sm7 PLSEum6DFs B...
SYNTHES PROXIMAL HUMERAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
CLEARFIL REPAIR
FDA 510(k)
FDA Class 2
·Dental
SLEEK PTA DILATATION CATHETER
FDA Adverse Event
Injury
·CLEARSTREAM TECHNOLOGIES LTD·Product code LIT·June 8, 2012
PERFEKTUM MATCHED NUMBER GLASS SYRINGES
FDA Adverse Event
Malfunction
·CADENCE INC.·Product code FMF·March 29, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
FDA Adverse Event
Malfunction
·COCHLEAR LTD·Product code MCM·March 29, 2011
CYCLESURE BIOLOGICAL INDICATOR
FDA Adverse Event
Malfunction
·AVAIL MEDICAL PRODUCTS·Product code FRC·April 22, 2008
TRIATHLON #4 PS INSERT 11MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·August 23, 2013
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