285 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MOD. DM-357 BICARBONATE RETROFIT KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACUMED
FDA UDI
Acumed LLC·10806378044625·3.0mm Clavicle Screw Step Drill
Acumed
FDA UDI
Provision·B504OM8007720·
BONEMEDIK-DM
FDA 510(k)
FDA Class 2
·Dental
MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)
FDA 510(k)
FDA Class 2
·Anesthesiology
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·May 8, 2014
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 22, 2012
NEW LIGASURE 5MM
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·August 4, 2010
ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code DYB·September 28, 2016
DURAMAX 15.5 F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31 cm from Tip), DuraMax Stacked Tip 36 cm Str. Basic Kit, Catalog No./REF 10302806, STERILE --- AngioDynamics, Inc. 603 Queensbury, NY 12804 USA The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code MSD·January 24, 2011
DURAMAX 15.5 F x 32 cm Chronic Hemodialysis Catheter Set (With Cuff 27 cm from Tip), DuraMax Stacked Tip 32 cm Str. Basic Kit, Catalog No./REF 10302805, STERILE --- AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804 USA The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code MSD·January 24, 2011
DURAMAX 15.5 F x 28 cm Chronic Hemodialysis Catheter Set (With Cuff 23 cm from Tip), DuraMax Stacked Tip 28 cm Str. Basic Kit, Catalog No./REF 10302804, STERILE --- AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804 USA The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code MSD·January 24, 2011
DURAMAX 15.5 F x 24 cm Chronic Hemodialysis Catheter Set (With Cuff 19 cm from Tip), DuraMax Stacked Tip 24 cm Str. Basic Kit, Catalog No./REF 10302803, STERILE --- AngioDynamics, Inc. 603 Queensbury, NY 12804 USA The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code MSD·January 24, 2011
DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff 17 cm from Tip), DuraMax Stacked Tip 22 cm Str. Basic Kit, Catalog No./REF 10302802, STERILE --- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code MSD·January 24, 2011
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046, 2) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO S PG, Item Number H787065970485, Catalog No. REF 06597048 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code DYB·September 28, 2016
AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code DQO·June 15, 2012
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO S PG, Item Number H787065970705, Catalog No.REF 06597070 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code DYB·September 28, 2016
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number H787065970415, Catalog No. REF 06597041 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code DYB·September 28, 2016
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffened Micro-Introducer Kit, STF 4F M.I. KIT 45CM NT/T NON-ECHO S PG, Item Number H787065970695, Catalog No.REF 06597069 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code DYB·September 28, 2016
Vortex TR, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816
FDA Recall
Terminated
·Angiodynamics, INC·Product code FRN·September 27, 2010