621 results
·
10ms
·
Sources: EU EUDAMED, US FDA
AXIOM Artis dBA, Model Number 7555357
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
Axiom Artis dBA, Axiom Artis Modular Angiography X-Ray System, Model number 7555357.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZI·September 2, 2008
AXIOM Artis System dBA using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZI·August 25, 2008
OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Bracing, Biomet Osteobiologics) Parsippany, New Jersey 07054
FDA Recall
Terminated
·Product code MQV·October 23, 2007
Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.
FDA Recall
Terminated
·Value Plastics, Inc.·Product code FMG·December 18, 2015
ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.
FDA Recall
Terminated
·Innominata Dba Genbio·Product code LSR·February 11, 2013
EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401 Enterprise Pkwy, Suite 340, Beachwood, OH 44122. The EPIFLO System is intended to provide topical oxygen to treat 1.) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions 2.) Decubitus ulcers 3.) amputations/infected stumps 4.) skin grafts 5.) burns 6.) frostbite.
FDA Recall
Terminated
·Ogenix Corporation·Product code KPJ·April 16, 2012
NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-000
FDA Recall
Terminated
·Inverness Medical Professional Diagnostics·Product code MJH·September 29, 2006
Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of non-palpable lesions.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code GAA·May 6, 2008
PremierPro Aluminum Adjustable Walker
FDA Recall
Terminated
·SVS LLC·Product code ITJ·October 1, 2018
Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·March 13, 2015
CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·March 13, 2015
Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code LMH·February 26, 2015
***REF C9944A***"FULL RADIUS RESECTOR"***2.9mm***Qty 6***STERLING***STERILE***Rx Only.*** Made in the USA***Manufacturer: CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***ConMed Linvatec Biomaterials, Ltd.Hermiankatu 6-8L 33720 Tampere, FINLAND.***Lot number # 95987. Soft Tissue resection and removal.
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code GFA·November 12, 2009
NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code MBI·June 26, 2012
EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
FDA Recall
Terminated
·Natus Medical Incorporated 2568 Bristol Circle Oakville Canada Ontario·Product code GWF·January 2, 2015
"***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code MBI·June 26, 2012
Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
FDA Recall
Terminated
·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code KRA·September 23, 2011
"***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code MBI·June 26, 2012
"***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code MBI·June 26, 2012