1,069 results
·
18ms
·
Sources: EU EUDAMED, US FDA
McKesson Cardiology Hemo software
FDA Recall
Open, Classified
·A L I Technologies Ltd·Product code MWI·December 2, 2024
Change Healthcare Cardiology Hemodynamics software
FDA Recall
Open, Classified
·A L I Technologies Ltd·Product code MWI·December 2, 2024
Change Healthcare Cardiology Hemo software
FDA Recall
Open, Classified
·A L I Technologies Ltd·Product code MWI·December 2, 2024
Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, Item Number: DYNJSYRPP20R; d) SYRINGE 10ML RED L/L LOW PR, Item Number: DYNJSYRPP10R; e) SYRINGE 10ML GREEN L/L LOW PR, Item Number: DYNJSYRPP10G; f) SYRINGE 10ML WHITE L/L LOW PR, Item Number: DYNJSYRPP10W; g) SYRINGE CNTRL 10ML RED L/L LP, Item Number: DYNJSYCPP10R; h) SYRINGE 5ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP5Y; i) SYRINGE CNTRL 10ML YEL L/L LP, Item Number: DYNJSYCPP10Y; j) SYRINGE 3ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP3Y; k) SYRINGE 5ML WHITE L/L LOW PR, Item Number: DYNJSYRPP5W; l) SYRINGE,CONTROL,LL,FINGER GRIPS,10ML, Item Number: DYNJPOLYCON1
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FMF·April 17, 2024
Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic
FDA Recall
Open, Classified
·Orthofix U.S. LLC·Product code ODP·November 3, 2025
Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Parallel; 37-3108SP 12mm W X 12mm L, 8mm H, Parallel; 37-3109SP 12mm W X 12mm L, 9mm H, Parallel; 37-3110SP 12mm W X 12mm L, 10mm H, Parallel; 37-3111SP 12mm W X 12mm L, 11mm H, Parallel; 37-3112SP 12mm W X 12mm L, 12mm H, Parallel; 37-3113SP 12mm W X 12mm LW, 13mm H, Parallel; 37-3114SP 12mm W X 12mm WL, 14mm H, Parallel; 37-3006SP 12mm W X 12mm L, 6mm H, 5 Lordotic; 37-3007SP 12mm W X 12mm L, 7mm H, 5 Lordotic; 37-3008SP 12mm W X 12mm L, 8mm H, 5 Lordotic; 37-3009SP 12mm WL X 12mm L, 9mm H, 5 Lordotic; 37-3010SP 12mm W X 12mm L, 10mm H, 5 Lordotic; 37-3011SP 12mm W X 12mm L, 11mm H, 5 Lordotic; 37-3012SP 12mm W X 12mm L, 12mm H, 5 Lordotic; 37-3013SP 12mm W X 12mm L, 13mm H, 5 Lordotic; 37-3014SP 12mm W X 12mm L, 14mm H, 5 Lordotic; 37-3207SP 12mm W X 12mm L, 7mm H, 10 Lordotic; 37-3208SP 12mm W X 12mm L, 8mm H, 10 Lordotic; 37-3209SP 12mm W X 12mm L, 9mm H, 10 Lordotic; 37-3210SP 12mm W X 12mm L, 10mm H, 10 Lordotic; 37-3211SP 12mm W X 12mm L, 11mm H, 10 Lordotic; 37-3212SP 12mm W X 12mm L, 12mm H, 10 Lordotic; 37-4106SP 15mm W X 12mm L, 6mm H, Parallel; 37-4107SP 15mm W X 12mm L, 7mm H, Parallel; 37-4108SP 15mm W X 12mm L, 8mm H, Parallel; 37-4109SP 15mm W X 12mm L, 9mm H, Parallel; 37-4110SP 15mm W X 12mm L, 10mm H, Parallel; 37-4111SP 15mm W X 12mm L, 11mm H, Parallel; 37-4112SP 15mm W X 12mm L, 12mm H, Parallel; 37-4113SP 15mm W X 12mm L, 13mm H, Parallel; 37-4114SP 15mm W X 12mm L, 14mm H, Parallel; 37-4006SP 15mm W X 12mm L, 6mm H, 5 Lordotic; 37-4007SP 15mm W X 12mm L, 7mm H, 5 Lordotic; 37-4008SP 15mm W X 12mm L, 8mm H, 5 Lordotic; 37-4009SP 15mm W X 12mm L, 9mm H, 5 Lordotic; 37-4010SP 15mm W X 12mm L, 10mm H, 5 Lordotic; 37-4011SP 15mm W X 12mm L, 11mm H, 5 Lordotic; 37-4012SP 15mm W X 12mm L, 12mm H, 5 Lordotic; 37-4013SP 15mm W X 12mm L, 13mm H, 5 Lordotic; 37-4014SP 15mm W X 12mm L, 14mm H, 5 Lordotic; 37-4207SP 15mm W X 12mm L, 7mm H, 10 Lordotic; 37-4208SP 15mm W X 12mm L, 8mm H, 10 Lordotic; 37-4209SP 15mm W X 12mm L, 9mm H, 10 Lordotic; 37-4210SP 15mm W X 12mm L, 10mm H, 10 Lordotic; 37-4211SP 15mm W X 12mm L, 11mm H, 10 Lordotic; 37-4212SP 15mm W X 12mm L, 12mm H, 10 Lordotic; 37-5106SP 15mm W X 15mm L, 6mm H, Parallel; 37-5107SP 15mm W X 15mm L, 7mm H, Parallel 37-5108SP 15mm W X 15mm L, 8mm H, Parallel; 37-5109SP 15mm W X 15mm L, 9mm H, Parallel; 37-5110SP 15mm W X 15mm L, 10mm H, Parallel; 37-5111SP 15mm W X 15mm L, 11mm H, Parallel; 37-5112SP 15mm W X 15mm L, 12mm H, Parallel; 37-5113SP 15mm W X 15mm L, 13mm H, Parallel; 37-5114SP 15mm W X 15mm L, 14mm H, Parallel; 37-5006SP 15mm W X 15mm L, 6mm H, 5 Lordotic; 37-5007SP 15mm W X 15mm L, 7mm H, 5 Lordotic; 37-5008SP 15mm W X 15mm L, 8mm H, 5 Lordotic; 37-5009SP 15mm W X 15mm L, 9mm H, 5 Lordotic; 37-5010SP 15mm W X 15mm L, 10mm H, 5 Lordotic; 37-5011SP 15mm W X 15mm L, 11mm H, 5 Lordotic; 37-5012SP 15mm W X 15mm L, 12mm H, 5 Lordotic; 37-5013SP 15mm W X 15mm L, 13mm H, 5 Lordotic; 37-5014SP 15mm W X 15mm L, 14mm H, 5 Lordotic; 37-5207SP 15mm W X 15mm L, 7mm H, 10 Lordotic; 37-5208SP 15mm W X 15mm L, 8mm H, 10 Lordotic; 37-5209SP 15mm W X 15mm LW, 9mm H, 10 Lordotic; 37-5210SP 15mm W X 15mm L, 10mm H, 10 Lordotic; 37-5211SP 15mm W X 15mm L, 11mm H, 10 Lordotic; 37-5212SP 15mm W X 15mm L, 12mm H, 10 Lordotic;
FDA Recall
Open, Classified
·Orthofix U.S. LLC·Product code ODP·November 3, 2025
GORE CARDIOFORM ASD Occluder. cardiovascular implant.
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 21, 2022
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489
FDA Recall
Open, Classified
·W. L. Gore & Associates Inc.·Product code MJN·July 12, 2021
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code DSY·May 12, 2021
Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code PRL·September 7, 2021
REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code DSY·August 26, 2025
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *For Clinical use.
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code PRL·July 1, 2024
REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021