17 results · 21ms · Sources: EU EUDAMED, US FDA

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EasyPass Guidewire

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

OrthoMedFlex, LLC

FDA UDI
ORTHOMEDFLEX LLC·M7161121532640·Crossbar Acetabular Reamer - 64mm

VERCISE GEVIA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·September 19, 2022

PEDICLE SCREW REDUCTION PEDICLE SCREW 6X40

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·May 29, 2019

ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)

FDA 510(k)
FDA Class 2 ·Cardiovascular

ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·RICE CREEK MFG·Product code LWP·June 8, 2013

UNKNOWN ZIMMER RHK

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·June 30, 2011

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·ANIMAS CORP.·Product code LZG·September 8, 2008

BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 21, 2022

Artis zee biplane, Model Number 10094141

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

Artis zee biplane, Model Number 10094141

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. .

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 1, 2015

REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

FDA Enforcement
Class II ·Ongoing·Bard Peripheral Vascular Inc·October 13, 2021

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014

Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015