16 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)
FDA 510(k)
FDA Class 2
·Physical Medicine
CoRoent
FDA UDI
Nuvasive, Inc.·00887517571397·CoRoent Ant TLIF Ti, 15x10x30mm 8°
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613327029550·Tibial Bearing Insert - PS
Rx Knee PS Cemented Symmetrical Femur
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215122935·
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250308030·cM Paste 2D C / dental ceramic material
THERMAL CAUTERY PROBE
FDA 510(k)
FDA Class 2
·Ophthalmic
Palm TENS
FDA 510(k)
FDA Class 2
·Neurology
BD NEEDLE ECLIPSE 25X5/8
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·March 28, 2025
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 14, 2014
ATTAIN OTW
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·September 15, 2011
OPTIFLUX 200NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·July 24, 2013
NEEDLE ECLIPSE 25X5/8
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·August 13, 2025
MSS - HUMERAL REVERSE LINERS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·February 18, 2026
OT VERIO2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 8, 2017
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013