17 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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WINCO STRETCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306811579·Ferriera Retractor, 14mm x 7cm
Ring CT/MR Applicator
FDA UDI
Nucletron B.V.·08717213038547·Ring CT/MR Applicator Set, 45°, 4mm
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
FDA 510(k)
FDA Class 2
·Dental
POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 20, 2026
HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 20, 2026
ROUND FILTER POLYPROVPYLENE
FDA Adverse Event
Malfunction
·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013
BD LUER SLIP¿ TUBERCULIN SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·February 8, 2018
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
FREESTYLE FREEDOM LITE
FDA Adverse Event
Injury
·Product code NBW·June 1, 2011
SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·January 27, 2021
BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 18, 2022
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024