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