15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTRABEAM SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODEL 4300 PSARRAY EEG ELECTRODE SET
FDA 510(k)
FDA Class 2
·Neurology
9617032-2017-00160
FDA Adverse Event
Malfunction
·December 1, 2017
RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION
FDA Adverse Event
Injury
·BAUSCH & LOMB INCORPORATED·Product code LPN·February 18, 2020
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·April 10, 2013
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·May 22, 2008
CONTINUUM LONGEVITY CROSSLINKED POLY LINER
FDA Adverse Event
Injury
·ZIMMER INC·Product code JDI·April 5, 2011
ARROW MULTI-LUMEN/PSI KIT: 9FR X 4" (10 CM)
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code FOZ·August 17, 2020
ARROW PSI SET: 9 FR
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DYB·November 2, 2020
ARROW PSI KIT: 9 FR X 10 CM ANTIMICROBIAL
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DYB·September 27, 2021
ARROW MULTI-LUMEN/PSI SET
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code FOZ·March 24, 2020
ARROW PSI SET: 9 FR
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DYB·October 11, 2019
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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