12 results · 21ms · Sources: EU EUDAMED, US FDA

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Pounce™ Sheath

FDA 510(k)
FDA Class 2 ·Cardiovascular

inCoris ZI

FDA UDI
SIRONA Dental Systems GmbH·E27662318282·inCoris ZI meso F2 S 1 Piece

MILAGRO

FDA UDI
Medos International Sàrl·10886705022328·MILAGRO ADVANCE INTERFERENCE SCREW Absorbable -...

NATURALASE LP ND:YAG LASER

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR

FDA 510(k)
FDA Class 1 ·General Hospital

KII FIOS FIRST ENTRY

FDA Adverse Event
Malfunction ·APPLIED MEDICAL RESOURCES CORP·Product code GCJ·August 25, 2015

TEXIUM

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FMF·March 19, 2026

CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPRSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·November 11, 2008

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011

OUTLOOK ES

FDA Adverse Event
Malfunction ·B. BRAUN MEDICAL, INC.·Product code FRN·July 15, 2013

CTF03, 5X100 KII FIOS Z-THR 6/BX

FDA Adverse Event
Malfunction ·APPLIED MEDICAL·Product code GCJ·September 25, 2015

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