77 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 1, 2022
Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
FDA Recall
Terminated
·Sekisui Diagnostics P.E.I. Inc.·Product code JIF·November 29, 2016
Kit BD Max ExK TNA 2; Catalog # 442825
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JJH·July 17, 2019
Kit BD Max ExK DNA 1 USA; Catalog # 442817
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JJH·July 17, 2019
Kit BD Max ExK DNA 2 USA; Catalog # 442819
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JJH·July 17, 2019
Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code N/A·July 17, 2019
Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code N/A·July 17, 2019
Kit BD Max ExK TNA 2; Catalog # 442825
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Kit BD Max ExK DNA 1 USA; Catalog # 442817
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Kit BD Max ExK DNA 2 USA; Catalog # 442819
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code LDP·July 20, 2017
Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
FDA Enforcement
Class II
·Terminated·Sekisui Diagnostics P.E.I. Inc.·February 1, 2017
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·September 20, 2017
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.
FDA Recall
Terminated
·Karl Storz Endoscopy·Product code EQN·December 6, 2019
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
FDA Recall
Terminated
·Sekisui Diagnostics P.E.I. Inc.·Product code LDP·January 22, 2016
CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021