14 results
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31ms
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Sources: EU EUDAMED, US FDA
REARZ INC
FDA registration
REARZ INC·1 product·🇨🇦 Canada
FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU
FDA Adverse Event
Other
·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·April 5, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 6, 2016
Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
FDA Enforcement
Class II
·Terminated·Abbott Medical Optics, Inc.·July 17, 2013
Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360 UDI-DI code: (01)00628758003601 Raz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200 UDI-DI code: (01)00628758001003 Raz-AP (Attendant Propel) Mobile Shower Commode Chair, Catalog Number Z100 UDI-DI code: (01)00628758001003 The Raz Mobile Shower Commode Chair is intended to be used by people with mobility impairments, who may have difficulty in standing or keeping their balance while completing activities such as showering, toileting, or personal hygiene.
FDA Recall
Open, Classified
·Raz Design Inc·Product code INN·January 5, 2026
BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 " PBBCS w/PAH (Preattached), BD Diagnostics, Franklin Lakes, NJ
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·November 20, 2007
e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear medicine diagnostic device.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·April 23, 2014
Symbia E camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear medicine diagnostic device.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·April 23, 2014
BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder;Catalog Number : 367352: 21G x 3/4" x 12"; 0.8 x 19mm x 305mm, Wingset PBBCS, BD Diagnostics, Franklin Lakes, NJ
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·November 20, 2007
XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.
FDA Recall
Terminated
·Strata Skin Sciences, Inc.·Product code GEX·January 23, 2017
WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
FDA Recall
Open, Classified
·WHILL, INC. 2 Chome 1-11 Higashishinagawa Shinagawa Japan·Product code ITI·December 29, 2025
WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
FDA Recall
Open, Classified
·WHILL, INC. 2 Chome 1-11 Higashishinagawa Shinagawa Japan·Product code ITI·December 29, 2025
Symbia E camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear medicine diagnostic device.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 23, 2014
e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear medicine diagnostic device.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 23, 2014