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

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DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A

FDA 510(k)
FDA Class 2 ·Radiology

ELMED INCORPORATED

FDA UDI
ELMED INCORPORATED·00842180149168·ELMED TELESCOPIC BRIDGES - 1 INSTRUMENT CHANNEL

OsteoMed

FDA UDI
OSTEOMED LLC·00845694003490·15 Hole Comminuted Fracture Plate

Merit® Kit

FDA UDI
Merit Medical Systems, Inc.·00884450292235·

BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90

FDA 510(k)
FDA Class 3 ·Cardiovascular

MEDCOM RT-VIEWER SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

2124215-2014-16429

FDA Adverse Event
Malfunction ·GUIDANT PUERTO RICO BV·Product code NVY·October 3, 2014

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 25, 2011

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS INC.·Product code CBK·May 29, 2013

ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code MIH·August 25, 2020

ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS

FDA Adverse Event
Death ·WILLIAM COOK EUROPE·Product code MIH·October 5, 2022

Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013