12 results · 19ms · Sources: EU EUDAMED, US FDA

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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