19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITA VM LC Flow
FDA 510(k)
FDA Class 2
·Dental
2.5 LACTOSORB SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036070731·
Modular Liner Inserter
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215096038·
CALYPSO SYSTEM WITH DYNAMIC EDGE GATING
FDA 510(k)
FDA Class 2
·Radiology
QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUILL SRS
FDA Adverse Event
Malfunction
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·April 17, 2009
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code NEW·May 12, 2009
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 3, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 7, 2013
PLUM XLM W/MODIFD B
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 28, 2011
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DYB·May 4, 2018
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 28, 2025
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019
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
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024