12 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITROS Immunodiagnostic Products CK-MB Reagent Pack
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Bernafon
FDA UDI
Bernafon AG·05711584115060·CZ5 MNR T, 2.4G NFM SABE/MAC CORAL 5 GPL
ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN)
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code NCX·November 10, 2025
ASFORA BULLET CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano, TX St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 40 cm, 0.5 REF 6172 STERILE EO Rx ONLY St. Jude Medical Plano, TX Instructions For Use: Lead and Extension Kits for Deep Brain Stimulation Systems Clinician's Manual ST. JUDE MEDICAL - Product Usage: St. Jude Medical Deep Brain Stimulation (DBS)leads are intended to deliver stimulation to target areas in the brain. DBS extensions are intended to connect the leads to implantable pulse generators (IPGs). St. Jude Medical DBS leads are designed for introduction into the brain using standard stereotactic neurosurgical techniques. DBS system delivers electrical stimulation to a precisely targeted area in the brain. Leads are implanted in the brain and are connected to extensions, which are passed under the skin and are connected to the neurostimulator. Leads for the St. Jude Medical Infinity DBS System feature electrodes on a stiff distal end with an inactive lead tip. The proximal end of the lead contains contact bands that correspond with each of the distal electrodes and an inactive band that functions as a contact for a setscrew when connecting to a compatible extension. The 8-channel leads contain cylindrical and segmented electrodes. The segmented electrodes can be activated independently to focus stimulation in one direction to help target desired neurological structures. As stated in Clinician manual (ARTEN600008305 Rev A), leads materials which are intended to come into contact with tissue are Platinum-iridium and polycarbonate urethane. In addition, drawing for the Stim Tip, 1-3-3-1 Directional DBS lead requires that the electrode material shall be 90/10 Platinum Iridium.
FDA Enforcement
Class II
·Terminated·St. Jude Medical, Inc.·December 19, 2018
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·October 24, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·August 11, 2011
RESTORE ADVANCED
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LGW·July 9, 2013
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023