40 results
·
65ms
·
Sources: EU EUDAMED, US FDA
SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code LMG·October 24, 2024
CYBERONICS
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·July 17, 2012
TRISALUS TRINAV MICROCATHETER
FDA Adverse Event
Malfunction
·TRISALUS LIFE SCIENCES INC / SUREFIRE MEDICAL, INC.·Product code DQO·October 31, 2024
DERMAGRAFT-TC
FDA Adverse Event
Injury
·ADVANCED TISSUE SCIENCES, INC.·Product code MGR·September 18, 1998
MagNA Pure LC 1.0 (software version 3.0.11). Roche Diagnostics Operations, Inc. An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code LXG·July 21, 2011
MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24) Roche Diagnostics Operations, Inc. An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code LXG·July 21, 2011
MPS Medical Product service GmbH
Importer
🇩🇪 Germany·2 Manufacturers
Coupler System II Mizuho Orthopedic Systems, Inc. Union City, CA 94587 The 5873 Coupler II is designed for use specifically with the Mizuho OSI Modular Base and the Spinal System Table Tops (AKA Jackson Spinal Table Top). The Coupler II mounts onto the Spinal Surgery Top by using the Spinal Top Adaptor Brackets. The 5873 Coupler II is used to allow positioning of a patient on the table utilizing either a skull clamp or horseshoe headrest for cranial stabilization or support during surgical procedures. The Coupler II can be accommodate either a radiolucent or aluminum skull clamp manufactured by Integra Life Sciences, referred to as a Mayfield clamp or the radiolucent or aluminum skull clamp referred to as the DORO which is manufactured by pro med instruments Inc.
FDA Recall
Terminated
·Mizuho Orthopedic Systems Inc·Product code FWZ·February 27, 2012
MPS Medical Product Service GmbH
Authorized representative
🇩🇪 Germany·35 Manufacturers·1959 Devices
VASCULAR THERAPY
Importer
🇫🇷 France·6 Manufacturers
AF Pharma Service Europe SL
Authorized representative
🇪🇸 Spain·51 Manufacturers·881 Devices
Kaster S.r.l.
Importer
🇮🇹 Italy·5 Manufacturers
Genodynamic SRL
Importer
🇷🇴 Romania·6 Manufacturers
AB Medical Group Eesti OÜ
Importer
🇪🇪 Estonia·8 Manufacturers
Medical Technology Promedt Consulting GmbH
Authorized representative
🇩🇪 Germany·194 Manufacturers·10009 Devices
SLOVAKIA MEDICAL, s.r.o.
Importer
🇸🇰 Slovakia·9 Manufacturers
Medica, medicinska zastopstva, trgovina, marketing in posredovanje, d.o.o.
Importer
🇸🇮 Slovenia·6 Manufacturers
mdi Europa GmbH
Authorized representative
🇩🇪 Germany·132 Manufacturers·4741 Devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
QbD RepS BV
Authorized representative
🇧🇪 Belgium·86 Manufacturers·1555 Devices