10 results · 20ms · Sources: EU EUDAMED, US FDA

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AVISO OPHTHALMIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES

FDA 510(k)
FDA Class 2 ·Cardiovascular

DIGITAL CLINICAL THERMOMETER, MODEL KD-193

FDA 510(k)
FDA Class 2 ·General Hospital

NONE - SEE PHYSICIAN COMMENTS IN H10.

FDA Adverse Event
Injury ·Product code JWH·October 16, 2013

IBAL UKA, TIBIAL IMPACTOR

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code LXH·May 23, 2024

PEN NDL 32G 4MM PRO 100 BOX 1200 CA

FDA Adverse Event
Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·April 3, 2025

MEDTRONIC.SIGMA

FDA Adverse Event
Injury ·MEDTRONIC S.A. (SMO)·Product code NVZ·April 10, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 15, 2011

CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code KRH·May 22, 2008

Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016