33 results · 25ms · Sources: EU EUDAMED, US FDA

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Gastric Alimetry

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

NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE

FDA 510(k)
FDA Class 2 ·Orthopedic

ANKYLOS DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

OCEAN WET SUCTION WATER SEAL DR

FDA Adverse Event
Malfunction ·ATRIUM MEDICAL CORP.·Product code KDQ·September 2, 2011

WAVELIGHT EX500 EXCIMER LASER

FDA Adverse Event
Injury ·WAVELIGHT GMBH·Product code LZS·November 5, 2014

TERUMO ADVANCED PERFUSION SYSTEM 1

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTQ·July 17, 2013

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

PKG, 3MM INSERT, DORSEY GRASPER, 20CM, P/N 0250282096 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

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