12 results
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26ms
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Sources: EU EUDAMED, US FDA
THE MAGNUM CHIN IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112002·3M™ Victory Series™ First Molar Bands, 902-285,...
ATAC PAK ALP REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90
FDA 510(k)
FDA Class 2
·Radiology
INFUSION DEVICES - UNKNOWN
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 4, 2024
INFUSION DEVICES - UNKNOWN
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 4, 2024
INFUSION DEVICES - UNKNOWN
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 4, 2024
DIMENSION® XPAND PLUS WITH HM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD·Product code JJE·January 8, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code MGB·November 11, 2010
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 24, 2014
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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