105 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack, part number AMS3785(B Podiatry Pack, part number AMS3785(C Podiatry Pack, part number AMS4011(A Podiatry Pack, part number PSS3422(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc·October 3, 2018
Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc·October 3, 2018
K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·August 21, 2019
K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·August 21, 2019
Major Kit, part number PHC1307(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Newport Coast Basic Pack, part number 007484-1
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Eye Tray, part number PSS1834 Eye Tray, part number PSS1834(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic Pack, part number AMS4309 Basic Pack, part number PSS1833 Basic Pack, part number PSS1833(A Basic Pack, part number PSS1848(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing
FDA Enforcement
Class II
·Terminated·Leica Biosystems Richmond Inc.·September 20, 2017
Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the SOX-10 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing..
FDA Enforcement
Class II
·Terminated·Leica Biosystems Richmond Inc.·September 20, 2017
Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods
FDA Enforcement
Class II
·Terminated·Leica Biosystems Richmond Inc.·September 20, 2017
Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy Pack, part number PSS2190(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Pacemaker Kit, part number AMS4281 Pacemaker Kit, part number AMS4281(A Pacemaker Kit, part number AMS4281(C Pacemaker Kit, part number AMS4281(D
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Percutaneous Entry Kit, part number TVS4022(D Percutaneous Entry Kit , part number TVS4022(E Percutaneous Entry Kit, part number TVS4022(F
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Thio Med w/Dex, Hem, Vit K (5ml) 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
Set Up Pack, part number PSS3574(A
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/Dex, Hem, Vit K(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