30 results · 26ms · Sources: EU EUDAMED, US FDA

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EffortMed Spinal Fixation System

FDA 510(k)
FDA Class 2 ·Orthopedic

IMMULITE® 2000 BR-MA

FDA 510(k)
FDA Class 2 ·Immunology

Compass BDS Biliary Stent

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

ONE TOUCH ULTRA METER

FDA Adverse Event
Injury ·LIFESCAN, INC.·Product code NBW·November 25, 2008

HYALGAN

FDA Adverse Event
Injury ·FIDIA FARMACEUTICI S.P.A·Product code MOZ·August 26, 2011

RESOLUTION CLIP CLIPPING DEVICE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·July 23, 2013

PKG, 5MM X 45CM INSERT, ALLIS FORCEPS, DOUBLE ROW TEETH, P/N 0250080754 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 DRAINAGE BAG

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

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

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

VALVE CAP

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·November 5, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

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