12 results
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19ms
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Sources: EU EUDAMED, US FDA
UMBILI-CATH CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
Bardia® Urethral Catheter
FDA UDI
C. R. Bard, Inc.·00801741018350·Bardia® Urethral Catheter - Red Rubber
OPTIFLUX F250NR, MODEL 0500325E
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
FDA 510(k)
FDA Class 2
·General Hospital
ST FRANCIS HSP TULSA OK 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·December 18, 2012
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 21, 2014
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·October 18, 2012
DEXTRUS 4135
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·May 28, 2015
BARD® RUBBER UTILITY CATHETER
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code KOD·September 3, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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