17 results · 23ms · Sources: EU EUDAMED, US FDA

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PlasmaBlade UPPP and Suction Coagulator

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

Oticon

FDA UDI
Oticon A/S·05707131287908·RIA2 PRO TI, MINIRITE 312 WL SIL

SYRINGE 3ML LL W/NDL 21X1-1/2 RB

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 2, 2020

BD SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 2, 2020

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTL.·Product code MNI·October 14, 2011

SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL

FDA Adverse Event
Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·June 2, 2020

PASS LP SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SOMATOM EMOTION 16

FDA 510(k)
FDA Class 2 ·Radiology

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011

GMK-REVISION FEMUR CEMENTED STD SIZE 5NARROW / RIGHT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 7, 2018

SYRINGE 3ML LL W/NDL 25X5/8 RB

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 1, 2020

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 7, 2014

PINNACLE PELVIC FLOOR REPAIR KITS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013

CORE UNIVERSAL DRIVER

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·June 7, 2011

SYRINGE 3ML LL W/NDL 25X1 RB

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 2, 2020

30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

FDA Adverse Event
Malfunction ·CHARTER MEDICAL, LTD.·Product code LPZ·April 13, 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