500 results
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11ms
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Sources: EU EUDAMED, US FDA
Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
Pencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
Perifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879, 551994, 552024. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·May 16, 2018
Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·February 26, 2020
Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·February 26, 2020
Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·February 26, 2020
Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry laparoscopic and general surgical instruments prior to final disinfection and sterilization as required.
FDA Enforcement
Class II
·Terminated·Steris Corporation·May 6, 2015
Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·February 26, 2020
Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·February 26, 2020
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)
FDA Enforcement
Class II
·Terminated·Ortho Clinical Diagnostics Inc·November 25, 2020
Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
FDA Enforcement
Class II
·Terminated·The Magstim Company Limited·May 20, 2020
Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
FDA Enforcement
Class II
·Terminated·The Magstim Company Limited·May 20, 2020