10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEONICS 7000 SERIES TOTAL KNEE BONE AUGMENTATION
FDA 510(k)
FDA Class 2
·Orthopedic
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110966·STERILIZING CASE 4-KNIVES
PATIENTNET MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENTERPRISE2 4MMX16MM NO TIP
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·June 16, 2022
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 24, 2019
MESH-COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·December 6, 2010
ACCENT
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·December 7, 2012
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021