73 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code PEZ·April 9, 2021
Kit: Blood Culture. MAI Kit Part Number: 80315D
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code OFM·April 9, 2021
Kit: Injection REVIEW MAI Kit Part Number: 74736
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code OGJ·April 9, 2021
Kit: Blood Culture MAI Kit Part Number: 80076
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code OFZ·April 9, 2021
Kit: Midline Insertion DA. MAI Kit Part Number: 77981B
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code OFF·April 9, 2021
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code PEZ·April 9, 2021
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
ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4" x 4.5" pad. There are 5 pouches per box. Ref: SD4X4.5; Part Number: IF-151023 and IF-151026. The product is labeled in parts: "***5 DRESSINGS***4 X 4.5 INCHES***REF SD4X4.5***PART NO. 5001826***ON-Q SilverDressing is a silver containing adhesive transparent polyurethane film for fixation and securement of devices to the skin as a primary contact sound dressing***MANUFACTURED BY ACRYMED***DISTRIBUTED BY I-FLOW***AcryMed, Inc Beaverton, OR 97008***". Intended for use in securing devices such as catheters to the skin. Also intended for use as a primary or secondary cover wound dressing on surgical incision sites.
FDA Recall
Terminated
·Acrymed Incorporated·Product code FRO·June 30, 2008
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
FDA Recall
Terminated
·MTI Precision Products LLC.·Product code EFB·May 7, 2012
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
FDA Enforcement
Class II
·Terminated·MTI Precision Products LLC.·July 23, 2014
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 Recall
Terminated
·Angiodynamics, Inc.·Product code DYB·September 28, 2016