14 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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NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033842·Baltic Denture System BDLoad BDLoad Sw6 PLSEbm...
PRESCOTT'S SURGICAL SPEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
IMMUNO-TROL LOW CELLS
FDA 510(k)
FDA Class 2
·Hematology
ACCU-CHEK FLEXLINK
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·July 20, 2007
ACCU-CHEK FLEXLINK
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·March 29, 2007
ACCU-CHEK FLEXLINK
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·July 20, 2007
ACCU-CHEK FLEXLINK
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·March 29, 2007
COULTER® ACT DIFF HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·April 3, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·March 23, 2011
STOCKERT RF GENERATOR
FDA Adverse Event
Injury
·STOCKERT GMBH·Product code DRF·April 24, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
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