26 results · 25ms · Sources: EU EUDAMED, US FDA

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iPico Product Usage: Muscle stimulation

FDA Recall
Terminated ·Ion Genius, Inc.·Product code NFO·January 6, 2012

IELLIOS Product Usage: Muscle stimulation

FDA Recall
Terminated ·Ion Genius, Inc.·Product code NFO·January 6, 2012

CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531

FDA Recall
Open, Classified ·Family Dollar Stores, Llc.·Product code LPN·June 23, 2022

B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as 50 bulk nonsterile units per pouch, 2 pouches per shipping carton.

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code DYB·May 8, 2006

CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040

FDA Recall
Completed ·Townsend Design·Product code IQI·September 23, 2023

SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037

FDA Recall
Completed ·Townsend Design·Product code IQI·September 23, 2023

EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation

FDA Recall
Terminated ·EEG Info·Product code HCC·November 15, 2012

V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; Manufactured by Centurion Medical Products for Neo Medical; 42514 Albrae Street, Fremont, CA 94538

FDA Recall
Terminated ·Neo Medical, Inc.·Product code LRS·April 5, 2011

Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

FDA Recall
Terminated ·NEO METRICS, INC.·Product code OCY·March 31, 2014

Plicator EPS Plication System Catalog Number: 160-01128R

FDA Recall
Terminated ·NDO Surgical, Inc.·Product code KOG·January 26, 2007

Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.

FDA Recall
Terminated ·Helena Laboratories, Corp.·Product code GFO·January 5, 2021

Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.

FDA Recall
Terminated ·Helena Laboratories, Corp.·Product code GFO·December 7, 2017

HemosIL SynthAFax. Partial Thromboplastin Time Tests.

FDA Recall
Open, Classified ·Instrumentation Laboratory·Product code GFO·November 18, 2025

Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

FDA Recall
Terminated ·ITC-Nexus Dx·Product code GFO·December 19, 2013

TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.

FDA Recall
Terminated ·Abeon Medical Corporation·Product code FFO·November 25, 2015

TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.

FDA Recall
Terminated ·Abeon Medical Corporation·Product code FFO·November 25, 2015

Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.

FDA Recall
Terminated ·Diagnostica Stago, Inc.·Product code GFO·July 18, 2006

Staclot LA 20 (REF 00594) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).

FDA Recall
Terminated ·Diagnostica Stago, Inc.·Product code GFO·November 14, 2018

Staclot LA (REF 00600) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).

FDA Recall
Terminated ·Diagnostica Stago, Inc.·Product code GFO·November 14, 2018

Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code GFO·March 25, 2015