11 results
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23ms
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Sources: EU EUDAMED, US FDA
VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED
FDA 510(k)
FDA Class 1
·General Hospital
CONMED
FDA UDI
Conmed Corporation·10845854000755·ROUND DIAMOND BUR, EXTRA LONG, 4MM
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450457139·
MICRO STAMPING LIGATING CLIP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 5, 2013
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code MNT·September 16, 2014
ZIMMER TIV LAG SCREW
FDA Adverse Event
Malfunction
·ZIMMER INC·Product code HWC·May 3, 2011
BD ULTRA FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 31, 2022
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
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015