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

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Tyber Medical Wedge System

FDA 510(k)
FDA Class 2 ·Orthopedic

SR PIP

FDA UDI
Stryker GmbH·00886385019864·SIZE 3: PIP PROXIMAL BROACH ASSEMBLY (ORANGE)

DIOLASE 10S

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MEMO 3D SEMIRIGID ANNULOPLASTY RING

FDA 510(k)
FDA Class 2 ·Cardiovascular

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Injury ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 18, 2018

VITALITY 2

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 21, 2011

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·UNKNOWN·Product code IOR·June 14, 2013

ZERO TIP NITINOL STONE RETRIEVAL BASKET

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code FFL·September 17, 2008

ESOPHYX Z

FDA Adverse Event
Injury ·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·June 22, 2017

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

EVEREST ® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·STRYKER-SPINE·Product code LXH·September 9, 2019

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Death ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 26, 2018

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