10 results · 23ms · Sources: EU EUDAMED, US FDA

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EL27-Compact; Sterile EHL-Probes

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Bernafon

FDA UDI
Sbo Hearing A/S·05714464031405·AO7 MNR T SABE/MAC ALIGO 7

PERKINS RETRACTOR

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896026728·PERKINS RETRACTOR LEFT BLADE

FLUORILAQ

FDA 510(k)
FDA Class 2 ·Dental

emField

FDA 510(k)
FDA Class 2 ·Physical Medicine

SILICONE ADVANCING OPTIC-VIOLET SHIELD

FDA Adverse Event
Malfunction ·BAUSCH & LOMB·Product code HQL·November 7, 2008

PULSE GEN MODEL UNK

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code LYJ·August 12, 2011

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 16, 2013

CODMAN Disposable Perforator, 14mm. Cranial perforator.

FDA Enforcement
Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

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