43 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Recall
Terminated
·American Surgical Company·Product code EFN·March 31, 2016
Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.
FDA Recall
Terminated
·Ortho Solutions Inc·Product code HSB·April 19, 2017
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
FDA Recall
Terminated
·Medtronic Navigation, Inc.-Littleton·Product code OWB·November 15, 2019
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
FDA Recall
Terminated
·Covidien Llc·Product code NEY·September 29, 2021
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.-Littleton·January 8, 2020
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
FDA Enforcement
Class II
·Terminated·Covidien Llc·November 17, 2021
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
FDA Enforcement
Class II
·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·December 22, 2021
Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.
FDA Enforcement
Class II
·Terminated·Ortho Solutions Inc·August 9, 2017
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
FDA Enforcement
Class II
·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·December 22, 2021
Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.
FDA Recall
Terminated
·Medtronic Xomed, Inc.·Product code ERL·June 12, 2020
Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single Use
FDA Enforcement
Class II
·Terminated·Medtronic Neurosurgery·October 3, 2018
- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile.
FDA Recall
Terminated
·Medela Inc. EF Division·Product code FMF·February 13, 2015
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc. Biopsy Needle Kit (9733068) Note: This device is an accessory to your StealthStation System. . . The Biopsy Needle is a presterilized , single-use, side-cutting needle for cranial tissue biopsies. CE 0344 Rx Only 2017-05 9733068-01 Medtronic Navigation, Inc.
FDA Enforcement
Class I
·Terminated·Medtronic Navigation, Inc.·January 9, 2019
- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile.
FDA Enforcement
Class II
·Terminated·Medela Inc. EF Division·March 18, 2015
Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
FDA Recall
Terminated
·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015
Optilite IgG4 Kit Product Code: LK009.OPT.A
FDA Recall
Terminated
·The Binding Site Group, Ltd.·Product code CFN·December 23, 2016
Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P Product Code LK009.H/LK001.H This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents
FDA Recall
Terminated
·The Binding Site Group, Ltd.·Product code CFN·September 11, 2014
Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code CFN·December 15, 2006
IMMAGE IGALC Reagent Part Number: 447460
FDA Recall
Terminated
·Beckman Coulter Inc·Product code CFN·June 6, 2003
TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
FDA Recall
Terminated
·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015