14 results
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19ms
·
Sources: EU EUDAMED, US FDA
FESAN SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981170424·Cannulated Screw Caddy
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707051747·.022 U6R DBT/NC -14T 5 OFF
TISSU TRANS FILTRON SYRINGE FILL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCENAR, MODEL 10
FDA 510(k)
FDA Class 2
·Neurology
SCREWDRIVER SHAFT, COMPRESSION T2 TIBIA 3.5 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HXX·July 27, 2012
STATSPIN MP
FDA Adverse Event
Malfunction
·IRIS INTERNATIONAL·Product code GKG·May 6, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·November 10, 2010
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·January 8, 2013
MINMED QUICK SET
FDA Adverse Event
Injury
·UNOMEDICAL UM-D·Product code FPA·January 17, 2025
AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 1, 2016
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 Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024