22 results · 21ms · Sources: EU EUDAMED, US FDA

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CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES

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

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08809282811722·

MicroSelectron Digital

FDA UDI
Nucletron B.V.·08717213015302·microSelectron Transfer Tube for 6F Flexible (15)

Summa Orthopaedics System Surgical Instrument

FDA UDI
Jeil Medical Corporation·08806390869027·

PTA-DUO PTA BALLOON CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT

FDA 510(k)
FDA Class 2 ·Orthopedic

ZENIX

FDA UDI
Zoll Medical Corporation·00198843000346·ZENIX, HOSPITAL FULLY LOADED CONFIGURATION

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·March 4, 2022

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 29, 2015

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 14, 2013

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 23, 2014

UNKN SUTUREFIX ANCHOR

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBI·November 11, 2024

UNKN NON-ABSORBABLE SUTURE AND TAPE

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code GAT·November 11, 2024

UNKN NON-ABSORBABLE SUTURE AND TAPE

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code GAT·November 11, 2024

UNKN NON-ABSORBABLE SUTURE AND TAPE

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code GAT·November 4, 2024

UNKN SUTUREFIX ANCHOR

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBI·November 4, 2024

UNKN SUTUREFIX ANCHOR

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBI·November 11, 2024

OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

FDA Enforcement
Class II ·Terminated·Oscor, Inc.·December 28, 2016

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·March 8, 2017

Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

FDA Enforcement
Class II ·Ongoing·Medtronic Neurosurgery·July 26, 2023