14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR
FDA 510(k)
FDA Class 2
·Physical Medicine
Mixing Tip 4.2T 48-Pack
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883002541·Dental material mixing nozzle, non-sterile
Mixing Tip 4.2T 48pk
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172019293·Dental material mixing nozzle, non-sterile
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033032·Baltic Denture System BDLoad Lw6 PLSEbil2DFl C4...
INSTANT-VIEW Methamphetamine (1000) Urine Cassette Test
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000320·INSTANT-VIEW Methamphetamine (1000) Urine Casse...
LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL
FDA 510(k)
FDA Class 2
·Hematology
PHYSIOLOG, SERIES 95000
FDA 510(k)
FDA Class 2
·Cardiovascular
SCHILLER
FDA Adverse Event
Malfunction
·SCHILLER AG·Product code MHX·November 2, 2006
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·December 9, 2025
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 3, 2013
COLLEAGUE CXE1 PUMP UNREFURB
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - BUFFALO GROVE·Product code FRN·March 29, 2011
HI PWR DISPOSBL GRNDING PAD
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code ODR·April 22, 2008
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