64 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
FDA Enforcement
Class II
·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
Brow Pack, part number PSS1785(C
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Surgical Pack, part number PSS3540(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Dr. Casey Pack, part number AMS4313(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
FDA Enforcement
Class II
·Terminated·Accelerate Diagnostics Inc·May 2, 2018
Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
FDA Enforcement
Class II
·Terminated·Vivorte, Inc.·July 14, 2021
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
General Plastics Pack, part number 008617-1
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Custom Pack - with Introducer Kit, part number TVS4011NI(L
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code CGS·July 18, 2018
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code CGS·July 18, 2018
Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as a reagent in a 4L bottle. Intended for use as a kit in special stain techniques.
FDA Enforcement
Class II
·Terminated·Richard-Allan Scientific Company·May 10, 2017
Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.
FDA Recall
Terminated
·Envoy Medical Corporation·Product code OAF·June 28, 2018
Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Enforcement
Class II
·Terminated·Remel Inc·May 29, 2019
Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
FDA Recall
Terminated
·Cochlear Americas Inc.·Product code LXB·December 18, 2018
Hand Tray, part number PSS2365(F Hand Tray, part number PSS2365(G
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm
FDA Recall
Terminated
·Angiotech (Manan Medical Products, Inc.)·Product code DWO·December 18, 2018
Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation
FDA Recall
Terminated
·Human Design Medical Llc·Product code NOU·May 8, 2018