21 results
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20ms
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Sources: EU EUDAMED, US FDA
K-C HEMOSTATIC BIOPSY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117506·Distal Reamer (Hudson)
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690111627·Modular Stem 13mm x 150mm
IDI Dental Implant
FDA UDI
AIDI BIOMEDICAL LLC·D747IDI10501351·IDI Implant Fixture 5.0mm x 13.5mm
(Implant Pack)
IDI Dental Implant
FDA UDI
AIDI BIOMEDICAL LLC·D747IDI1050135A1·IDI Implant Fixture 5.0mm x 13.5mm
(Practice Bu...
IDI Dental Implant
FDA UDI
AIDI BIOMEDICAL LLC·D747IDI105013501·IDI Implant Fixture 5.0mm x 13.5mm
(Implant Only)
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
FDA 510(k)
FDA Class 2
·Physical Medicine
PRO.DUCT CATHETER, MODEL CTH03
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523117932·SA Cervical Screw 3.5mm Self Drilling, 20mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523117925·SA Cervical Screw 3.5mm Self Drilling, 18mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523117918·SA Cervical Screw 3.5mm Self Drilling, 16mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523117901·SA Cervical Screw 3.5mm Self Drilling, 14mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523117895·SA Cervical Screw 3.5mm Self Drilling, 12mm
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 29, 2020
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Enforcement
Class II
·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·April 10, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 30, 2014
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 1, 2011
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Recall
Open, Classified
·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025
CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.
FDA Enforcement
Class II
·Terminated·Veridex, LLC·March 19, 2014