16 results
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29ms
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Sources: EU EUDAMED, US FDA
Zeta Corporation
Manufacturer
🇺🇸 United States·1 Importer
ZETA CORPORATION
FDA registration
ZETA CORPORATION·3 products·🇺🇸 United States
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·December 13, 2011
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·December 13, 2011
medac GmbH
Importer
🇩🇪 Germany·7 Manufacturers
AETAS CORPORATION
FDA registration
AETAS CORPORATION·1 product·🇺🇸 United States
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the Alair Bronchial Thermoplasty Catheter) is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·July 24, 2013
Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of Source Train (IST), Novoste Corporate, 3890 Steve Reynolds Blvd, Norcross, GA 30093, Tel: +1770-717-0904, Fax: +1770-717-1283, 1-800-NOVOSTE (1-800-668-6783), www.novoste.com.
FDA Recall
Terminated
·Novoste Corporation·Product code JAJ·January 25, 2002
Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the Alair Bronchial Thermoplasty Catheter) is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code OOY·May 28, 2013
SEPTODONT
Importer
🇫🇷 France·11 Manufacturers
MARRODENT SP. Z O. O.
Importer
🇵🇱 Poland·17 Manufacturers
Amstermed B.V.
Authorized representative
🇳🇱 Netherlands·50 Manufacturers·272 Devices
ABALASE MEDICAL PRODUCTS LTD
Importer
18 Manufacturers
American Dental Systems GmbH
Importer
🇩🇪 Germany·37 Manufacturers
KTR Europe GmbH
Authorized representative
🇩🇪 Germany·135 Manufacturers·3461 Devices