9 results · 27ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

PRESTIGE® LP Cervical Disc System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994490728·PUNCH 6972426 RAIL

ATLAS SPINE PEDICLE SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Clear Blue Digi LED Curing Light

FDA 510(k)
FDA Class 2 ·Dental

PINNACLE MTL INS NEUT36IDX52OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·February 21, 2013

SIGMA HP UNI FEMORAL SZ5 LM/RL

FDA Adverse Event
Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NPJ·January 26, 2011

UNKNOWN DEPUY ASR FEMORAL HEAD

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·August 1, 2014

PECTUS SYSTEM JANTON 12" TI PECTUS BAR 3.048CM (12") (L) TITANIUM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·January 2, 2019

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