14 results · 31ms · 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.

Instant 20s Indicator

FDA 510(k)
FDA Class 2 ·General Hospital

TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE

FDA 510(k)
FDA Class 1 ·Dental

LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,

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

CANN CONNECTING SCR F/PERCUTANINSTRUMENTS FOR NAILS-EX

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code FZX·October 13, 2016

CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code FZX·December 6, 2016

MEDLINE UNITE

FDA Adverse Event
Injury ·MEDLINE INDUSTRIES, LP·Product code JDR·December 23, 2025

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 13, 2014

TECNIS

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·August 12, 2011

RIATA ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013

CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code FZX·September 30, 2016

INSERTION HANDLE FOR SUPRAPATELLAR

FDA Adverse Event
Malfunction ·SYNTHES SELZACH·Product code JDS·September 30, 2016

CANN CONNECTING SCR F/PERCUTANINSTRUMENTS FOR NAILS-EX

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code FZX·December 10, 2014

CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FZX·May 1, 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