109 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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First SIGN SARS-CoV-2 Antigen Test
FDA Recall
Terminated
·WHPM Inc.·Product code QKP·March 4, 2022
First SIGN SARS-CoV-2 Antigen Test
FDA Enforcement
Class II
·Terminated·WHPM Inc.·April 13, 2022
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·January 13, 2016
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
FDA Recall
Terminated
·Ethicon, Inc. US·Product code PFJ·December 3, 2015
Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I
FDA Recall
Completed
·Applied Medical Technology Inc·Product code KNT·October 6, 2025
Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-N-I
FDA Recall
Completed
·Applied Medical Technology Inc·Product code KNT·October 6, 2025
Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06090-I
FDA Recall
Completed
·Applied Medical Technology Inc·Product code KNT·October 6, 2025
Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05090-I
FDA Recall
Completed
·Applied Medical Technology Inc·Product code KNT·October 6, 2025
Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06055-I
FDA Recall
Completed
·Applied Medical Technology Inc·Product code KNT·October 6, 2025
Manifold Kit. Catalog Number K09-11867AP
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code OJV·September 23, 2016
Fluid Management Set. Catalog Number K08-MP5159A
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code OJV·September 23, 2016
Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code OJV·September 23, 2016
Waste Management Kit. Catalog Number K10-04381AP
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code OJV·September 23, 2016
Cascade IOMAX Cortical Module, REF: 190296-200
FDA Recall
Open, Classified
·Cadwell Industries Inc·Product code GWF·May 17, 2024
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code OJV·September 23, 2016
Cascade IOMAX Cortical Module, REF: 190296-200
FDA Recall
Open, Classified
·Cadwell Industries Inc·Product code GWF·April 23, 2024
Permobil Chairman 2K powered wheelchair
FDA Recall
Terminated
·Permobile Inc.·Product code ITI·March 7, 2003
Osteofil ICM Moldable Strip of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
FDA Recall
Terminated
·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005
Osteofil RT, ICM Allograft Paste in varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
FDA Recall
Terminated
·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005
Product is REGENAFIL Allograft Paste, Syringe, 0.5cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
FDA Recall
Terminated
·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005