11 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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VITEK 2 GRAM NEGATIVE MEROPENEM
FDA 510(k)
FDA Class 2
·Microbiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450409190·
IMPROVED TRY-IN GEL
FDA 510(k)
FDA Class 2
·Dental
PF 5050 PRESSURE UNIT, MODEL PF 5050
FDA 510(k)
FDA Class 2
·Cardiovascular
BD 10ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 23, 2020
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
PINN MULTIHOLE W/GRIPTION 60MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 3, 2013
TRILOGY 100
FDA Adverse Event
Death
·RESPIRONICS, INC.·Product code CBK·August 20, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 18, 2011
ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·January 26, 2018
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