75 results
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17ms
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Sources: EU EUDAMED, US FDA
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The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·June 2, 2021
MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
FDA Enforcement
Class II
·Ongoing·Unetixs Vascular, Inc.·March 8, 2023
ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.
FDA Enforcement
Class II
·Terminated·Horiba Instruments, Inc dba Horiba Medical·July 4, 2018
Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.
FDA Enforcement
Class II
·Terminated·C P Medical, Inc.·November 5, 2014
Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 FLX-207-00, FLX-207-01, FLX-207-02, FLX-230-00, FLX-230-01, FLX-230-02 FLX-207-10, FLX-207-11, FLX-230-10
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 10, 2023
VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS Chemistry Products AcP Slides quantitatively measure acid phosphatase (AcP) activity in serum and plasma using VITROS 950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·November 27, 2013
Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 10, 2023
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
FDA Enforcement
Class II
·Terminated·Inpeco S.A.·May 16, 2018
Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·July 8, 2015
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·July 8, 2015
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·October 20, 2021
Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·July 8, 2015
Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·June 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·June 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·June 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·June 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·June 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·June 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·June 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·June 16, 2021