18 results
·
23ms
·
Sources: EU EUDAMED, US FDA
CooperSurgical Milex® Pessaries
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813058008·STERILE CARBIDE BUR FG36 DARBY
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250438050·ceraMotion® PZr Ingot B3, 5 x 2 g / dental cera...
STEALTHSTATION SYSTEM UPDATE
FDA 510(k)
FDA Class 2
·Neurology
Force Fiber OrthoTape suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 14, 2019
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019
NAVLOCK UNIVERSAL GREEN TRACKER
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·October 30, 2015
SCREW DRIVER
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·August 5, 2019
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·September 15, 2011
THUNDERBEAT 5MM, 35CM FRONT ACTUATED GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·November 7, 2014
DURAMER(R) ADVANTIM(R) POST STAB LSI TIBIAL INSERT
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JWH·July 26, 2013
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·May 18, 2018
NAV THORACIC PROBE TIP
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC.·Product code OLO·August 27, 2014
MSS - HUMERAL REVERSE LINERS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·February 18, 2026
NEUROLOGICAL STEREOTAXIC INSTRUMENT
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·October 26, 2015
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024