11 results · 24ms · 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.

MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER

FDA 510(k)
FDA Class 2 ·Orthopedic

CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR

FDA 510(k)
FDA Class 2 ·Ophthalmic

SURGICAL INSTRUMENTS & ACCESSORIES

FDA 510(k)
FDA Class 1 ·Dental

ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FCG·July 16, 2014

EON IMPLANTABLE PULSE GENERATOR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 23, 2010

RESTORE SENSOR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 30, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 15, 2014

ECHOTIP ULTRA ULTRASOUND ASPIRATION NEEDLE

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FCG·November 19, 2010

ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·July 29, 2014

ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FCG·September 17, 2014

Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code ISL·March 1, 2011