14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STA R MAX
FDA 510(k)
FDA Class 2
·Hematology
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00887868267215·
ORTHOPEDIC SALVAGE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304688018·
VICOR PD2I ANALYZER
FDA 510(k)
FDA Class 2
·Cardiovascular
GRANDIO
FDA 510(k)
FDA Class 2
·Dental
BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 10, 2023
ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·July 6, 2011
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013
OCTRODE
FDA Adverse Event
Injury
·ST JUDE MED NEUROMODULATION·Product code GZB·October 6, 2014
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·May 31, 2017
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014