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

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TriMed Bridge Plates

FDA 510(k)
FDA Class 2 ·Orthopedic

MIDLINE II TI

FDA 510(k)
FDA Class 2 ·Orthopedic

M2376A DEVICELINK SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

TENSIONER

FDA Adverse Event
Malfunction ·SYNTHES HAGENDORF·Product code LXH·November 20, 2014

BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·August 27, 2018

TENSIONER

FDA Adverse Event
Malfunction ·SYNTHES HAGENDORF·Product code LXH·November 20, 2014

BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 29, 2019

BD ULTRA-FINE¿ INSULIN SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·June 21, 2018

PUNCTUA

FDA Adverse Event
Death ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·September 9, 2011

ADAPTER SLEEVES 12/14 +2

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·November 10, 2014

DEPUY ASR XL FEM IMP SIZE 51

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·July 22, 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

Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.

FDA Enforcement
Class II ·Terminated·Synthes USA HQ, Inc.·December 4, 2013

TENSIONER

FDA Adverse Event
Malfunction ·SYNTHES HAGENDORF·Product code LXH·November 20, 2014