Or Co L L C

FDA Filings

This page includes the latest FDA filings for Or Co L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

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• Ortho-Clinical Diagnostics, Inc.100 Indigo Creek Dr.rochester, NY 14626-5101 PMA NumberP030026 Supplement NumberS037 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Ortho-Clinical Diagnostics, Inc.100 Indigo Creek Dr.rochester, NY 14626-5101 PMA NumberP090028 Supplement NumberS018 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• ORTHO-CLINICAL DIAGNOSTICS100 Indigo Creek Dr.rochester, NY 14626-5101 PMA NumberP100001 Supplement NumberS017 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• OrganOx Limitedoxford Science Park, Magdalen Centre, Robert Robinson Avenueoxford OX4 4 PMA NumberP200035 Supplement NumberS003 Date Received06/07/2022 Decision Date07/07/2022 Product Code QQK  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Orthofix, Inc.3451 Plano Parkwaylewisville, TX 75056 PMA NumberP030034 Supplement NumberS017 Date Received03/16/2022 Decision Date06/14/2022 Product Code LOF  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Orthofix, Inc.3451 Plano Parkwaylewisville, TX 75056 PMA NumberP850007 Supplement NumberS046 Date Received03/16/2022 Decision Date06/14/2022 Product Code LOF  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• OrganOx Limitedoxford Science Park, Magdalen Centre, Robert Robinson Avenueoxford OX4 4 PMA NumberP200035 Supplement NumberS002 Date Received03/21/2022 Decision Date05/27/2022 Product Code QQK  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• OrganOx Limitedoxford Science Park, Magdalen Centre, Robert Robinson Avenueoxford OX4 4 PMA NumberP200035 Supplement NumberS001 Date Received03/15/2022 Decision Date04/12/2022 Product Code QQK  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Organon Teknika Corporation LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019113053255	Ningpo ,China (Mainland) -> Seattle, Washington	LAPAROSCOPIC INSTRUMENTS ACCESSORY HOT PACK THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	18 PKG
2019111157744	Kaohsiung,China (Taiwan) -> Tacoma, Washington	MEDICAL DEVICES 314 CTNS RECEIVED IN 16 PLTS .	314 CTN
2019111157743	Kaohsiung,China (Taiwan) -> Tacoma, Washington	UTERINE MANIPULATOR INJECTOR 20 CTNS RECEIVED .	20 CTN
2019062242	Kaohsiung,China (Taiwan) -> Tacoma, Washington	INSUFFLATOR NEEDLE - 150MM - ORC HOLSTOR PRO 250MM HOLSTOR PRO 330MM INSTRUMENT HOLDER LAR	241 PCS
2019020531095	Shanghai ,China (Mainland) -> Seattle, Washington	LAPAROSCOPIC INSTRUMENTS ACCESSORY	157 CTN
2019012322663	Yantian,China (Mainland) -> Seattle, Washington	INSUFFLATION TUBING SET HS CODE9018.90	483 CTN
2018120847262	Shanghai ,China (Mainland) -> Seattle, Washington	LAPAROSCOPIC INSTRUMENTS ACCESSORY HOT PACK	13 PKG
201811092371	Yantian,China (Mainland) -> Tacoma, Washington	INSUFFLATION TUBING SET -FUNNEL CONNECTOR INS UFFLATION TUBING SET -QUICK DISCONNECT CONNEC	201 PCS
201811092371	Yantian,China (Mainland) -> Tacoma, Washington	INSUFFLATION TUBING SET -FUNNEL CONNECTOR INS UFFLATION TUBING SET -QUICK DISCONNECT CONNEC	201 PCS