11 results · 19ms · 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.

ADVANTA GRAFT (>6MM)

FDA 510(k)
FDA Class 2 ·Cardiovascular

Monolith

FDA UDI
Nuvasive, Inc.·00887517677419·Monolith Endcap, 19x16mm Lord 10° Ø14

ADVIA® Chemistry MG_c Magnesium Reagents, Concentrated

FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414526713·Magnesium - ADVIA Chem. - RGT - 6x1270 tests

MILENIA(TM) PCP

FDA 510(k)
FDA Unclassified ·Unknown

LINDQUIST MODEL SS POWERED MUSCLE STIMULATOR

FDA 510(k)
FDA Class 2 ·Physical Medicine

TARGET ADAPTER T2 SCN

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 21, 2012

PFC SIGMA STAB INS SZ3 10MM

FDA Adverse Event
Injury ·DEPUY (IRELAND) 9616671·Product code JWH·March 7, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·February 7, 2011

ATTAIN OTW

FDA Adverse Event
Injury ·MPRI·Product code LWP·August 8, 2014

VERSA-DIAL 46X21X50 HUM HEAD

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code MBF·April 6, 2022

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