20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CR 10-X DIGITIZER
FDA 510(k)
FDA Class 2
·Radiology
ArgenZ HT+ 98x16 A4
FDA UDI
ARGEN CORPORATION, THE·D818121948·Dental porcelain/ceramic restoration kit
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295015017·PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE AC...
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295015024·PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE AC...
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295015000·PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE AC...
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295014997·PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE AC...
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295015048·PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE AC...
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295015031·PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE AC...
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295014973·PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE AC...
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295014980·PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE AC...
LUCIUS 62
FDA 510(k)
FDA Class 2
·Dental
WINGEATER V2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD ULTRA FINE PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMI·January 17, 2020
BD FACSLYRICS 3L10C INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 1, 2022
PUMP
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FHW·August 29, 2018
MINIARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·May 15, 2013
S5 MAST ROLLER PUMP AND CONTROL PANEL MAST ROLLER PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·June 2, 2011
TRILOGY AB ACETABULAR SYSTEM ALTERNATE BEARING SHELL INSERT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code KWB·August 13, 2008
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020