10 results
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19ms
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Sources: EU EUDAMED, US FDA
LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033335·Baltic Denture System BDLoad BDLoad ↓ Mn7 PLSEu...
RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER
FDA 510(k)
FDA Class 2
·General Hospital
QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
FDA 510(k)
FDA Class 2
·Hematology
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 3, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 25, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 21, 2011
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
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021