20 results · 23ms · Sources: EU EUDAMED, 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