18 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CODMAN
FDA UDI
Cerenovus, Inc.·10886704002482·CODMAN Slimline Temporary Aneurysm Clip No 7 Bl...
24M - Nevada Energy - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588011639·24M - Nevada Energy - Metal
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383549547·"An absorbent paper points is an endodontic pap...
SYNTHETIC POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
IT/IF CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Widex
FDA UDI
Widex A/S·05706069728293·Widex EVOKE E-FS (Titanium grey S-220 ) Telecoi...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 16, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO HEALTHCARE EQUIPMENT·Product code IOR·October 27, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
ETHIBOND EXCEL POLYESTER SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·July 2, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 9, 2012
BD NEXIVA CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 14, 2020
UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·September 20, 2021
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025