57 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Thio Med w/Dex, Hem, Vit K (9ml) 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
Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers.
FDA Enforcement
Class II
·Terminated·Sysmex America, Inc.·September 5, 2018
Thio Med w/o Ind, w/Dex (9ml) 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
In-Line ventilator adaptor
FDA Enforcement
Class I
·Terminated·Baxter Healthcare Corporation·June 8, 2022
Open Procedure Pack II, part number RMS1740(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Basic Tray, part number PSS1559(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Thio Med w/Dex, Hem, Vit K (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
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
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
Catheter Pack, part number AMS4399(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Set-Up Pack, part number PSS1305(C
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Laparoscopic Pack, part number AMS2499 Laparoscopic Pack, part number AMS2499(A Laparoscopic Pack, part number AMS2499(B
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Thio Med w/o Ind, w/Dex (10ml) 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
Breast Pack, part number AMS3238(A Breast Pack, part number AMS4419(A Breast Pack, part number AMS4419(B Breast Pack, part number AMS5750 Breast Pack, part number AMS5750(A Breast Pack, part number AMS6120 Breast Pack, part number PSS1784(B Breast Pack, part number PSS2272(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor Pack, part number PSS3541(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
FDA Recall
Terminated
·Arthrex, Inc.·Product code LXH·December 17, 2019
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators during transportation, and in hospital, institutional, and home care environments. It can be used while the Vivo ventilators is operating, for example mounted on a wheelchair, in a personal vehicle, or carried by hand. The device is not to be used with the protective cover while positioned in a warm place, such as in direct sunlight or close to a radiator. The protective cover includes the following features: transparent window for accessing front panel and buttons; port for patient circuit, cables, O2 inlet, and standby button; cooling air inlet; patient air inlet; straps for safe mounting; and cooling air outlet.
FDA Enforcement
Class II
·Terminated·Breas Medical, Inc.·March 4, 2020
GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code MUE·May 16, 2019
Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·May 17, 2019