16 results · 24ms · Sources: EU EUDAMED, 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