2,622 results
·
59ms
·
Sources: EU EUDAMED, US FDA
AMO COMPLETE MOISTUREPLUS
FDA Adverse Event
Injury
·ADVANCED MEDICAL OPTIONS, INC.·Product code LPN·June 18, 2007
HAMILTON MEDICAL AG
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·June 19, 2023
OPTION ELITE RETRIEVABLE VENA CAVA FILTER
FDA Adverse Event
Malfunction
·ARGON MEDICAL DEVICES, INC.·Product code DTK·September 30, 2020
thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general surgical procedures for electrocoagulation and hemostasis; " Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; " Non-invasive treatment of wrinkles and rhytids. The Thermage CPT System ( System ) consists of the RF Generator/ Cooling System, 16.00 cm2 Handpiece ( Body Handpiece ), Standard Handpiece with Vibration ( Face Handpiece ), optional electric Footswitch, accessory cables, Return Pad, Return Pad Cable, and Treatment Tips.
FDA Enforcement
Class II
·Ongoing·Solta Medical Inc·April 19, 2023
BIOLOX OPTION, HEAD, M¸ 32/0, TAPER 8/10
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code LZO·June 1, 2016
CARTIVA SCI IMPLANT FOR MTP
FDA Adverse Event
Malfunction
·CARTIVA, INC·Product code PNW·February 25, 2022
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·July 13, 2009
PULSE GEN MODEL 1000
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·June 2, 2025
SMARTPHONE ANDROID APP: PUMP CONNECT
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·January 11, 2024
SMARTPHONE ANDROID APP: PUMP CONNECT
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·January 9, 2024
SMARTPHONE ANDROID APP: PUMP CONNECT
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·January 19, 2024
SMARTPHONE ANDROID APP: PUMP CONNECT
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·January 10, 2024
AMBIT ELECTRONIC INFUSION PUMP
FDA Adverse Event
Malfunction
·AVANOS MEDICAL INC.·Product code FRN·May 18, 2026
Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 12722-65. Intended use: for the administration of fluids.
FDA Enforcement
Class II
·Terminated·Hospira Inc.·August 1, 2012
CLAVE NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FOZ·December 1, 1995
ENTERRA II IPG
FDA Adverse Event
Malfunction
·ENTERRA MEDICAL, INC·Product code LNQ·March 18, 2024
THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·December 15, 2019
TREO ABDOMINAL STENT-GRAFT SYSTEM
FDA Adverse Event
Malfunction
·BOLTON MEDICAL, INC.·Product code MIH·July 1, 2024
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·November 17, 2020
SMARTPHONE ANDROID APP: PUMP CONNECT
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·January 2, 2024