18 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PANTHER Cutter Stapler
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169524347·TRIAL 2152618 LARGE 12 DEGREES 18MM
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575419180·Proximal Tibial Spacer,Size large, incl. flat h...
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575419197·Proximal Tibial Spacer,Size large, incl. flat h...
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575419203·Proximal Tibial Spacer,Size large, incl. flat h...
IMAGECAST PACS
FDA 510(k)
FDA Class 2
·Radiology
VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED
FDA 510(k)
FDA Class 2
·Anesthesiology
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 18, 2019
I-STAT 6+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2017
BRAVO PH CAPSULE DELIVERY DEVICE
FDA Adverse Event
Injury
·GIVEN IMAGING·Product code FFT·October 2, 2014
MAXIMO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 7, 2013
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD.·Product code JAA·June 22, 2011
VERSAFITCUP CC FLAT PE HC LINER Ø 36/G
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 11, 2016
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
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
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017