61 results
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12ms
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Sources: EU EUDAMED, US FDA
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
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
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
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
Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·June 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·June 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·June 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·June 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·June 16, 2021