32 results
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21ms
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Sources: EU EUDAMED, US FDA
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
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
- 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
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
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.
FDA Recall
Terminated
·The Binding Site Group, Ltd.·Product code CFN·November 6, 2018
Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM 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
Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T 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
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.
FDA Recall
Terminated
·The Binding Site Group, Ltd.·Product code CFN·July 25, 2018
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
FDA Recall
Terminated
·The Binding Site Group, Ltd.·Product code CFN·July 29, 2019
IMMAGE IGMLC Reagent Part Number: 447470
FDA Recall
Terminated
·Beckman Coulter Inc·Product code CFN·June 6, 2003
MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit 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
TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (5/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