22 results · 26ms · Sources: EU EUDAMED, US FDA

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GENESIS REUSABLE RIGID CONTAINER SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...

APEX™

FDA UDI
B. BRAUN MEDICAL INC.·04046964539282·EVA Dual-Chamber Final Containers 3000 mL

Unity

FDA UDI
DIOMEDICAL CO.,LTD.·08800039821308·SIJ Standard Thread OD12.5xL35

SurgyCut

FDA UDI
U.S. SURGITECH INC.·00810014631349·SurgyCut J - Wire Hand Control Electrode, 5mm/35cm

ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

FDA 510(k)
FDA Class 2 ·Microbiology

DRG DISPOSABLE VAGINAL SPECULUM

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

PENCAN®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025

ECHI GREENVILLE NC 2

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011

ECHI GREENVILLE NC 2

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·November 30, 2011

STONYBROOK HSP NY NY 1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code OEZ·September 15, 2015

XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·May 14, 2013

SECURE 3 MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·May 25, 2011

LIFEPAK 20E DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·August 11, 2008

DELTA LINERS & ACCESSORIES

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A·Product code LPH·March 6, 2026

C21785 IT TREVISO

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code GEI·December 14, 2012

PENCAN®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025

D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTM·May 18, 2022

D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTM·March 17, 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