15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TAMPAX C PLASTIC TAMPONS, UNSCENTED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN
FDA Adverse Event
Malfunction
·TAMBRANDS MANUFACTURING, INC·Product code HEB·March 10, 2021
TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN
FDA Adverse Event
Malfunction
·TAMBRANDS MANUFACTURING, INC·Product code HEB·March 3, 2021
Ring CT/MR Applicator
FDA UDI
Nucletron B.V.·08717213038523·Ring Applicator Set, CT-MR 4 mm
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306817144·Wieder Breast & Facial Retractor, 28mm Serrated...
ULTRA FAST-FIX ASSEMBLY - CURVED
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code GAT·August 25, 2023
CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1
FDA 510(k)
FDA Class 2
·Neurology
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·September 9, 2022
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014
ACCUSOL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CASTLEBAR·Product code KPO·June 1, 2011
Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
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