30 results
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7ms
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Sources: EU EUDAMED, US FDA
OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 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
OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 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
OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 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
Hand Tray, part number PSS2365(F Hand Tray, part number PSS2365(G
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Upper Extremity Pack, part number AMS4670 Upper Extremity Pack, part number AMS4670(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 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
Morris Lap Pack, part number PSS3199(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
D & C Kit, part number CMP1466(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Bayview Breast Pack, part number 009080-2
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Hernia Pack, part number AMS3859
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Custom Venous Kit, part number TVS4024(C
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Upper Torso Tray, part number PSS1554(B
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Morris Hysto Pack, part number PSS3198(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Transvaginal Pack, part number CMP1767
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Laminectomy Pack, part number PSS1844(B
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Thio Med w/o Ind, w/Dex (18ml) 100/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
OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 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
Catheter Pack, part number AMS4399(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
PKG, DEBANEY FORCEPS, P/N 0250080314. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014