27 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from the eye. It has been designed as a disposable (single use)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Surgical Vision Inc·July 10, 2019
Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·October 12, 2016
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·October 12, 2016
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·October 12, 2016
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
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
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
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 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
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·October 12, 2016
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
12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES INC·May 24, 2017
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
10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES INC·May 24, 2017
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 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
16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES INC·May 24, 2017
14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES INC·May 24, 2017
Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers.
FDA Enforcement
Class II
·Terminated·Parker Laboratories, Inc.·November 5, 2014
16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES INC·May 24, 2017