11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
FDA 510(k)
FDA Class 2
·Hematology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032827·Baltic Denture System BDLoad ↓ Sm7 PLSEum6DFs A...
PORTA AURIUM, MODEL 2067
FDA 510(k)
FDA Class 2
·Dental
MAC ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
NONE - SEE PHYSICIAN COMMENTS IN H10.
FDA Adverse Event
Injury
·Product code JWH·October 16, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 3, 2013
3 LEAD EXTENSION SET W/INTERLINK INJECTION SITE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code FPA·March 29, 2011
PUMP MMT-722NAL PRDGM INSULIN CL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·April 21, 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