29 results · 23ms · Sources: EU EUDAMED, US FDA

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Rezum System

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

N/A

FDA UDI
GEORGE TIEMANN & CO.·B5821604170·FORCEPS, RONGEUR, SURGICAL

B-P TOTAL HIP SYSTEM

FDA UDI
ENDOTEC, INC.·00814193024244·B-P MODULAR EXTENSION W/ULTRACOAT - 17 MM X 100 MM

XKNIFE 5

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

BD MICRO-FINE IV INSULIN SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·January 5, 2021

PLEURX LOCKABLE DRAINAGE LINE SET

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·April 2, 2026

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026

SENSIA DR

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2013

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code FRN·September 20, 2014

TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GCJ·June 20, 2011

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026

KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012

PERITX DRAINAGE BAG

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·April 3, 2026

PLEURX DRAINAGE KIT 500ML 10/CS

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·July 25, 2025

PLEURX DRAINAGE KIT 1000ML

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·January 20, 2026

RADIFOCUS GLIDEWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025

PLEURX DRAINAGE KIT 1000ML

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·October 15, 2025

PERITX DRAINAGE BAG KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·December 18, 2025

TERUMO RADIFOCUS GUIDE WIRE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025