31 results
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36ms
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Sources: EU EUDAMED, US FDA
MANUFACTURAS KE
FDA registration
MANUFACTURAS KE·7 products·🇲🇽 Mexico
MANUFACTURAS Y SERVICIOS INTERNACIONALES, S. DE R.L.
FDA registration
MANUFACTURAS Y SERVICIOS INTERNACIONALES, S. DE R.L.·8 products·🇲🇽 Mexico
FLEX - PEN
FDA Adverse Event
Injury
·NOVO NORDISK·Product code FMI·June 28, 2013
THERMALATOR
FDA Adverse Event
Malfunction
·FABRICACION Y MANUFACTURAS DE MEXICO S.A.DE C.V.·Product code IRQ·December 9, 2021
WHITEHALL
FDA Adverse Event
Malfunction
·FABRICACION Y MANUFACTURAS DE MEXICO S.A. DE C.V.·Product code IRQ·November 29, 2018
DICKSON PARAFFIN BATH
FDA Adverse Event
Injury
·FABRICACION Y MANUFACTURAS DE MEXICO S.A. DE C.V.·Product code IMC·June 5, 2018
Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B; The product is manufactured by: BioGenex Laboratories, Inc. 4600 Norris Canyon Road San Ramon, CA 94583 and Distributed by: Abbott Molecular, 1300 E. Touhy Ave - 2E, Des Plaines, IL 60018 Xmatrx Automated Staining System is intended for in vitro diagnostic use. It is suitable for fluorescent hybridization (FISH) applications.
FDA Recall
Terminated
·Biogenex Laboratories·Product code KEY·January 23, 2009
PROCESOS DE MANUFACTURA SOCIEDAD POR ACCIONES SIMPLIFICADA
System producer
🇨🇴 Colombia
Flexible Intubation Fiberscope, Model # 11301AB1
FDA Recall
Terminated
·Karl Storz Endoscopy·Product code EOQ·April 24, 2019
Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2; b) SPOT VISION SCREENER,W/O CASE,PLUG4/UK, VS100-4; c) SPOT VISION SCREENER,W/O CASE,PLUG7/SA, VS100-7; d) SPOT VISION SCREENER,W/CASE,PLUG2/EUR, VS100S-2; e) SPOT VISION SCREENER,W/CASE,PLUG4/UK, VS100S-4; f) SPOT VISION SCREENER,W/CASE,PLUG7/SA, VS100S-7; g) SPOT VISION SCREENER W/CASE, BRAZIL, VS100S-Z; h) SPOT VS POWER SUPPLY SET/PLUG2/EUR, 106364; i) SPOT VS POWER SUPPLY SET/PLUG4/UK, 106366; j) SPOT VS POWER SUPPLY SET/PLUG7/SA, 106368; for use during vision screening
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code DXN·March 26, 2024
Arazy Group (Ireland) Ltd.
Authorized representative
🇮🇪 Ireland·17 Manufacturers·425 Devices
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFST-2; b) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,UK, Product Code 34BFST-4; c) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,AU, Product Code 34BFST-6; d) PROBP 3400, BLUETOOTH, MOBILE, EU, Product Code 34BXST-2; e) PROBP 3400, BLUETOOTH, MOBILE, UK, Product Code 34BXST-4; f) PROBP 3400, BLUETOOTH, MOBILE, ZA, Product Code 34BXST-7; g) PROBP 3400, SUREBP, MOBILE, EU, Product Code 34XFST-2; h) PROBP 3400, SUREBP, MOBILE, UK, Product Code 34XFST-4; i) PROBP 3400, SUREBP, MOBILE, AU, Product Code 34XFST-6; j) PROBP 3400, SUREBP, MOBILE, ZA, Product Code 34XFST-7; k) PROBP 3400, MOBILE, EU, Product Code 34XXST-2; l) PROBP 3400, MOBILE, UK, Product Code 34XXST-4; m) PROBP 3400, MOBILE, AU, Product Code 34XXST-6; n) PROBP 3400, MOBILE, ZA, Product Code 34XXST-7; o) PROBP MOBILE STAND CORD ASSY EUROPE, Product Code PWCD-5WT-2; p) PROBP MOBILE STAND CORD ASSY UK, Product Code PWCD-5WT-4; q) PROBP MOBILE STAND CORD ASSY AUST, Product Code PWCD-5WT-6; r) PROBP MOBILE STAND CORD ASSY S. AFRICA, Product Code PWCD-5WT-7; s) PROBP MOBILE STAND CORD ASSY EUROPE, Product Code PWCD-6WT-2; t) PROBP MOBILE STAND CORD ASSY AUST, Product Code PWCD-6WT-6; u) PROBP MOBILE STAND CORD ASSY S. AFRICA, Product Code PWCD-6WT-7
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code DXN·March 26, 2024
Philips Medical Systems Nederland B.V.
Authorized representative
🇳🇱 Netherlands·21 Manufacturers·1029 Devices
Mediclog Sanitaria, S.L.
Importer
🇪🇸 Spain·12 Manufacturers
PROCLINIC SAU
Importer
🇪🇸 Spain·33 Manufacturers
GE Medical Systems SCS
Authorized representative
🇫🇷 France·27 Manufacturers·564 Devices
Internacional Ventur S.A.
Importer
🇪🇸 Spain·23 Manufacturers
Hofmeester Dental B.V.
Importer
🇳🇱 Netherlands·16 Manufacturers
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices
Plandent Oy
Importer
🇫🇮 Finland·43 Manufacturers