19 results
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23ms
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Sources: EU EUDAMED, US FDA
UPnRIDE
FDA 510(k)
FDA Class 2
·Physical Medicine
Rabbit anti-c-Met Concentrate
FDA UDI
LIFE TECHNOLOGIES CORPORATION·10190302008075·
Halyard
FDA UDI
Avanos Medical, Inc.·10680651406207·HYH,BASIC,S-SHOT,-,-,20
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122292·Kwire .070X9" (1.8x225mm)
Sklar®
FDA UDI
SKLAR CORPORATION·10649111100062·BARRETT TEN FCP DEL 6 1/2"
ZENO AI ECO DISC
FDA 510(k)
FDA Class 2
·Dental
NANOCERAM- BRIGHT
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 12, 2021
COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·October 21, 2024
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 21, 2013
HEARTSTART SLA BATTERY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DQA·August 4, 2014
COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·March 29, 2024
COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·March 28, 2024
COOK CVC SINGLE LUMEN CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·December 28, 2023
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024