19 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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V-STRUT® Vertebral Implant
FDA 510(k)
FDA Class 2
·Orthopedic
NuVasive
FDA UDI
Nuvasive, Inc.·00887517441867·Universal T-Handle, Transverse Connector
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776345075·Spinal Fusion Curette, size 000000
MSI
FDA UDI
Modern Surgical Instruments LLC·B419102400840·
Zavation IBF System
FDA 510(k)
FDA Class 2
·Orthopedic
LIFESTYLE CIRCULATORY ENHANCER
FDA 510(k)
FDA Class 2
·Anesthesiology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014
QUICK FLEX LV LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code OJX·September 9, 2011
ENDOTAK C
FDA Adverse Event
Injury
·HISTORICAL CPI ST. PAUL·Product code NVY·July 22, 2013
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
FDA Enforcement
Class II
·Ongoing·Micro Therapeutics, Inc.·June 22, 2022
ATTAIN PERFORMA S MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code OJX·November 18, 2024
ATTAIN STABILITY QUAD MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code OJX·November 18, 2024
ATTAIN PERFORMA STRAIGHT MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code OJX·November 18, 2024
ATTAIN PERFORMA MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code OJX·November 18, 2024
IM REAMER, AO FITTING BIXCUT Ø8,0X480 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·April 2, 2014
IM REAMER, AO FITTING BIXCUT Ø7,5X480 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·April 2, 2014
IM REAMER, AO FITTING BIXCUT Ø8,0X480 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·April 2, 2014
IM REAMER, AO FITTING BIXCUT Ø8,5X480 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·April 2, 2014
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·May 18, 2016