863 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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THREAD RETRIEVAL DRILL REF 2224
FDA Recall
Terminated
·Zimmer Dental Inc·Product code DZA·July 10, 2017
ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L). BIOMET 3i 455 Riverside Drive, Palm Beach Gardens, FL 33410 USA. Made in Switzerland. Twist drill for preparation of osteotomy during dental implant surgical drilling procedure.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZA·June 29, 2009
AXIOM Artis dBA, Model Number 7555357
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
AXIOM Artis dBA, Model Number 7555357
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
Elekta Synergy The Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
FDA Recall
Terminated
·Elekta, Inc.·May 6, 2011
Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
FDA Recall
Terminated
·Accelerate Diagnostics Inc·Product code PRH·March 14, 2018
Axiom Artis dBA, Axiom Artis Modular Angiography X-Ray System, Model number 7555357.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZI·September 2, 2008
AXIOM Artis System dBA using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZI·August 25, 2008
Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
FDA Enforcement
Class II
·Terminated·Accelerate Diagnostics Inc·May 2, 2018
Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture 883-0062, Japan, Distributed by Boston scientific Corporation One Boston Scientific Place, Natick, MA 01760-1537 USA. Super Sheath 8F x 11 cm ,038 with Guide Wire BX/10 UPN H7491603508B1, Catalog # 16035-08B. Batch/Lot 11B15B6, 11B23B7, 11B28B9, 11C09BA, 11C16B9, 11C30B9. Super Sheath 8F x 11 cm ,038 without Guide Wire BX/10 , U PN M00115724B1, Catalog # 15-724B1. Batch/Lot 11C07B8. Super Sheath R/O 8 F x 11 cm without Guide Wire BX/10, M00159664B1, Catalog # 15-964B, Batch/Lot 11B01B4, 11B25B6. The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code DRE·November 3, 2011
Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.
FDA Enforcement
Class II
·Terminated·Value Plastics, Inc.·March 16, 2016
OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Bracing, Biomet Osteobiologics) Parsippany, New Jersey 07054
FDA Recall
Terminated
·Product code MQV·October 23, 2007
Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.
FDA Recall
Terminated
·Value Plastics, Inc.·Product code FMG·December 18, 2015
ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.
FDA Enforcement
Class II
·Terminated·Innominata Dba Genbio·March 20, 2013
ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.
FDA Recall
Terminated
·Innominata Dba Genbio·Product code LSR·February 11, 2013
EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401 Enterprise Pkwy, Suite 340, Beachwood, OH 44122. The EPIFLO System is intended to provide topical oxygen to treat 1.) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions 2.) Decubitus ulcers 3.) amputations/infected stumps 4.) skin grafts 5.) burns 6.) frostbite.
FDA Recall
Terminated
·Ogenix Corporation·Product code KPJ·April 16, 2012
Hospitak, REF 962-E, Adapter 22mm/15mm, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico
FDA Recall
Terminated
·Unomedical, Inc·Product code BZA·December 2, 2004
Hudson RICA Sheridan, EB Tube, Sher-I-Bronch, LS, 35FR, Nova Plus, 37FR, 39 FR, and 41 FR, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.
FDA Recall
Terminated
·Teleflex Medical·Product code BZA·July 31, 2009
Hudson RICA Sher-I-Swiv & Sher-I-Swiv F/O, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.
FDA Recall
Terminated
·Teleflex Medical·Product code BZA·July 31, 2009
Hospitak, REF CD1N4Y-E, Mapleson D. Anesthesia Non-Rebreathing Circuit, 10'', manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico
FDA Recall
Terminated
·Unomedical, Inc·Product code BZA·December 2, 2004