16 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012
FDA Enforcement
Class II
·Ongoing·Aomori Olympus Co., Ltd.·September 13, 2023
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
FDA Enforcement
Class I
·Terminated·Medical Action Industries, Inc. 306·May 19, 2021
Kit: Blood Culture. MAI Kit Part Number: 80315D
FDA Enforcement
Class I
·Terminated·Medical Action Industries, Inc. 306·May 19, 2021
Kit: Injection REVIEW MAI Kit Part Number: 74736
FDA Enforcement
Class I
·Terminated·Medical Action Industries, Inc. 306·May 19, 2021
Kit: Blood Culture MAI Kit Part Number: 80076
FDA Enforcement
Class I
·Terminated·Medical Action Industries, Inc. 306·May 19, 2021
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
FDA Enforcement
Class I
·Terminated·Medical Action Industries, Inc. 306·May 19, 2021
Kit: Midline Insertion DA. MAI Kit Part Number: 77981B
FDA Enforcement
Class I
·Terminated·Medical Action Industries, Inc. 306·May 19, 2021
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number H787065970415, Catalog No. REF 06597041 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
FDA Enforcement
Class III
·Terminated·Angiodynamics, Inc.·December 28, 2016
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffened Micro-Introducer Kit, STF 4F M.I. KIT 45CM NT/T NON-ECHO S PG, Item Number H787065970695, Catalog No.REF 06597069 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
FDA Enforcement
Class III
·Terminated·Angiodynamics, Inc.·December 28, 2016
Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
FDA Enforcement
Class II
·Terminated·MTI Precision Products LLC.·July 23, 2014
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
FDA Enforcement
Class II
·Ongoing·IN MY BATHROOM LLC·October 12, 2022
Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 ¿m (by weight) with narrow upper limit particle distribution. Component: N/A
FDA Enforcement
Class II
·Ongoing·Ultradent Products, Inc.·September 18, 2024
Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 ¿m (by weight) with narrow upper limit particle distribution. Component: N/A
FDA Enforcement
Class II
·Ongoing·Ultradent Products, Inc.·September 18, 2024
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·December 24, 2025