33 results
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17ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
FDA Enforcement
Class II
·Completed·New Standard Device Inc·June 15, 2022
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
FDA Recall
Completed
·New Standard Device Inc·Product code KTT·June 8, 2020
Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand.
FDA Enforcement
Class II
·Completed·RHONDIUM LIMITED·December 25, 2019
Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand.
FDA Recall
Completed
·RHONDIUM LIMITED·Product code EBF·January 31, 2019
Azurion systems with software release R2.0.x
FDA Enforcement
Class II
·Completed·Philips Healthcare·March 30, 2022
Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire
FDA Recall
Completed
·EYE COMFORT CARE LLC·Product code IRT·February 8, 2024
Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect.
FDA Recall
Completed
·GE Healthcare, LLC·Product code LLZ·November 9, 2018
Infusion Pump
FDA Recall
Completed
·Baxter Healthcare Corporation·Product code FRN·January 6, 2021
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
FDA Recall
Completed
·Abbott Molecular, Inc.·Product code MZP·July 19, 2022
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.
FDA Recall
Completed
·Cardinal Health 200, LLC·Product code KGO·July 29, 2020
PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.
FDA Recall
Completed
·Cardinal Health 200, LLC·Product code KGO·July 29, 2020
PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.
FDA Recall
Completed
·Cardinal Health 200, LLC·Product code KGO·July 29, 2020
PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.
FDA Recall
Completed
·Cardinal Health 200, LLC·Product code KGO·July 29, 2020
PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.
FDA Recall
Completed
·Cardinal Health 200, LLC·Product code KGO·July 29, 2020
PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.
FDA Recall
Completed
·Cardinal Health 200, LLC·Product code KGO·July 29, 2020
PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.
FDA Recall
Completed
·Cardinal Health 200, LLC·Product code KGO·July 29, 2020
microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059
FDA Recall
Completed
·Product code LHO·February 8, 2024
PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.
FDA Recall
Completed
·Cardinal Health 200, LLC·Product code KGO·July 29, 2020
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Recall
Completed
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·October 29, 2020
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
FDA Recall
Completed
·Caire, Inc.·Product code CAW·October 4, 2024