29 results
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14ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
FDA Recall
Open, Classified
·Abbott Diagnostics Scarborough, Inc.·Product code QWR·March 4, 2025
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
FDA Recall
Open, Classified
·Abbott Diagnostics Scarborough, Inc.·Product code QWR·March 4, 2025
Hologic QDR 4500 series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
FDA Recall
Terminated
·Hologic, Inc.·Product code KGI·April 7, 2009
Hologic Explorer series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
FDA Recall
Terminated
·Hologic, Inc.·Product code KGI·April 7, 2009
Hologic Delphi series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
FDA Recall
Terminated
·Hologic, Inc.·Product code KGI·April 7, 2009
Hologic Discovery series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
FDA Recall
Terminated
·Hologic, Inc.·Product code KGI·April 7, 2009
Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.
FDA Recall
Terminated
·Clerio Vision·Product code LPL·December 10, 2020
CT Goldseal BrightSpeed 16 PWR TIO 2 YR
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·May 24, 2018
Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software
FDA Recall
Terminated
·Hologic, Inc.·Product code KGI·September 24, 2008
Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
FDA Recall
Completed
·Lens.com·Product code LPM·August 14, 2018
Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
FDA Recall
Completed
·Allied Vision Group Inc·Product code LPM·August 1, 2018
Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
FDA Recall
Terminated
·Keystone Dental Inc·Product code NHA·July 5, 2011
Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
FDA Recall
Terminated
·Keystone Dental Inc·Product code NHA·July 5, 2011
Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Recall
Terminated
·Carestream Health Inc.·Product code LLZ·September 16, 2013
Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Recall
Terminated
·Carestream Health Inc.·Product code LLZ·September 16, 2013
Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Recall
Terminated
·Carestream Health Inc.·Product code LLZ·September 16, 2013
Carestream Vue PACS; Virtual PWR Reading Basic SW, 8 Pack The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Recall
Terminated
·Carestream Health Inc.·Product code LLZ·September 16, 2013
Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Recall
Terminated
·Carestream Health Inc.·Product code LLZ·September 16, 2013
Neulook Deluxe is packaged in a pink soft plastic box with white, black, and rainbow printing that reads, NeuLook COLOR CONTACT LENSES Give yourself a whole new look***LENS CASE INCLUDED HOT RED PWR. 0.00 LOT. BD53***EXP. 2014/08***Contents : Two sterile color contact lenses(62% Polymacon, 38% Water) Immersed in saline and one lens case. Caution : To ensure that your contacts stay comfortable and your Vision stay clear, ask your eye-care professional for product instruction. Made in Korea www.NeuLooklens.com Distributed by EYEZONE***1023 FDA 510K CLEARED***STERILE***B.C 8.6mm DIA. 14.0mm***8 806048 000468. The color contact lens colors are: Black out, vein, night, white cat, red cat devil, blue angelic, white out, and hot red. prescription contact lens
FDA Recall
Terminated
·Eyezone·Product code LPL·December 5, 2011
ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used with Anspach Systems
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code KWR·November 28, 2012