31 results · 28ms · Sources: EU EUDAMED, US FDA

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BioBrace® Reinforced Implant

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Trinity ELE Plus and Trinity ELE Plus Pro

FDA 510(k)
FDA Class 2 ·Neurology

EXACTECH 12/14 TOTAL HIP SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

TALENT ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC CARDIOVASCULAR·Product code MIH·November 19, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code BTI·July 22, 2013

SYRINGE 10ML REG PR SALINE 10ML FILL

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FOZ·April 7, 2025

PERITX DRAINAGE BAG

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

PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

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

BD POSIFLUSH SP

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code NGT·April 11, 2025

PLEURX DRAINAGE KIT 1000ML

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

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PLEURX DRAINAGE KIT 1000ML

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

PERITX

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·November 26, 2025