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

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TEST FOR KETONE IN URINE(ACETOACETIC AC

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Precept

FDA UDI
Nuvasive, Inc.·00887517351630·PRECEPT K-Wire, Threaded Blunt

Oph.Forceps

FDA UDI
KATENA PRODUCTS, INC.·00841668117743·Maumenee Colibri Forceps, .12mm, 1x2

Codman

FDA UDI
SYNERGETICS USA, INC.·20886704065446·Disposable Spetzler™-Malis® Standard Bipolar Fo...

SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311

FDA 510(k)
FDA Class 2 ·General Hospital

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

FORTIFY ASSURA DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·May 8, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 23, 2012

ASR ACETABULAR CUPS 48

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 11, 2010

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026