17 results
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21ms
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Sources: EU EUDAMED, US FDA
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