7 results
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16ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code NCF·June 30, 2017
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code NCF·June 30, 2017
Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, Product Codes: V5-10115, 5-10115, 5-10215 5) CF 8.0 mm, Product Codes: 5-10116, 5-10216, V5-10116 6) CF 8.5 mm, Product Codes: 5-10117, 5-10217 Product Usage: Tracheal tube/airway management
FDA Recall
Terminated
·Teleflex Medical·Product code BTR·May 24, 2019
7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Recall
Terminated
·Ortho Clinical Diagnostics Inc·Product code DCF·October 14, 2019
uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.
FDA Recall
Terminated
·Wako Life Sciences, Inc.·Product code DCF·April 30, 2013
Injection Needle, REF: 25207
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code GCF·October 24, 2023
Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code DCF·April 24, 2017