7 results
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34ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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BIOM PACK, Contents Individually Sterile. QTY 5 EA. Each Pack Contains: 1 EA. Microscope Drape (REF40100), 1 EA. Cornea Coat (REF 60010), 1 EA. SuperView BIOM Lens Set (REF 40411). Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994 USA. Item # 40201: Item Lot # Cornea Coat Lot # Expiration Date M423801008 M419300908 2010-07 M427731108 M419300908 2010-07 M428631008 M419300908 2010-07 M434211208 M422951008 2010-08 M439670109 M422951008 2010-08 M443700109 M435381208 2010-09 M44887 M442120109 2010-10 Item # 40202: Item Lot # Cornea Coat Lot # Expiration Date M427641008 M419300908 2010-07 M45414 M435381208 2010-09 Item # 40203: M416600908 M415950808 2010-06 M422941008 M416620908 2010-07 M427651108 M422951008 2010-08 M442710109 M435381208 2010-09 M44870 M442120109 2010-10 Item # 40204: Item Lot # Cornea Coat Lot # Expiration Date M421580908 M416620908 2010-07 M435201208 M422951008 2010-08 M45645 M435381208 2010-09 Item # 40205: Item Lot # Cornea Coat Lot # Expiration Date M410510708 M409570708 2010-05 M412790708 M409570708 2010-05 M419280908 M415950808 2010-06 M420850908 M415950808 2010-06 M421100908 M416620908 2010-07 M421120908 M416620908 2010-07 M424361008 M419300908 2010-07 M425821008 M421680908 2010-07 M426731008 M421680908 2010-07 M428601008 M419300908 2010-07 M429531108 M421680908 2010-07 M430851108 M421680908 2010-07 M431051108 M422951008 2010-08 M433111108 M422951008 2010-08 M435531208 M430041108 2010-09 M440700109 M430041108 2010-09 M441790109 M435381208 2010-09 M442560109 M430041108 2010-09 M443450109 M422951008 2010-08 M443930109 M442120109 2010-10 M44605 M442120109 2010-10 M44896 M44499 2010-11 M45099 M44499 2010-11 M45243 M435381208 2010-09 M45248 M44897 2010-12 M45866 M44897 2010-12 M45870 M435381208 2010-09 Item # 10206: Item Lot # Cornea Coat Lot # Expiration Date M418460908 M416620908 2010-07 M434741208 M422951008 2010-08 M45646 M435381208 2010-09
FDA Recall
Terminated
·Insight Instruments, Inc.·Product code KYG·May 12, 2010
ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07.
FDA Recall
Terminated
·Product code NIP·April 9, 2008
ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Lot 4401432, Use Before 2010-07. The IntraCoil is indicated for use in peripheral arteries in the leg in which balloon angioplasty has been applied. The IntaCoil stent is indicated for placement in flexing regions and a tortuous lesion.
FDA Recall
Terminated
·Product code NIP·April 2, 2008
Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740
FDA Recall
Terminated
·Ormco Corporation·Product code DYH·October 31, 2007
DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951 northwestern Avenue, Stillwater, MN 55082-0285, Lot 123127A, Exp. 2010//07/28.
FDA Recall
Terminated
·Diasorin Inc.·Product code LFX·December 16, 2009
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016