14 results
·
39ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Skeletal Dynamics Ulnar Shortening Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Synthes GmbH·10886982143280·1.8MM BUTTRESS PIN/12MM
S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY-
FDA 510(k)
FDA Class 2
·Ophthalmic
OLYMPUS ULTRASONIC SURGICAL SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·March 19, 2020
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·March 19, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020
GENESIS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 17, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCO·Product code CBK·June 27, 2013
INTRINSIC
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·July 2, 2019
CONTOUR TRANSTAR STAPLER SET
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 20, 2019
CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024
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