50 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm 132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm 132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm 232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm 232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm 232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm The IdentiTi ALIF Standalone Interbody System is an integrated intervertebral body fusion device for use in anterior lumbar interbody fusion (ALIF) procedures.
FDA Recall
Open, Classified
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code OVD·January 26, 2024
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US), 12mm x 40mm x 75cm (CFN CH12-40-75US)
FDA Recall
Open, Classified
·Product code LIT·September 19, 2024
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code LIT·December 3, 2025
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150, Size: 5MM X 60MM X 150CM; 6) AB14W050080090, Size: 5MM X 80MM X 90CM; 7) AB14W050080150, Size: 5MM X 80MM X 150CM; 8) AB14W050100150, Size: 5MM X 100MM X 150CM; 9) AB14W050120150, Size: 5MM X 120MM X 150CM; 10) AB14W050150150, Size: 5MM X 150MM X 150CM; 11) AB14W050200090, Size: 5MM X 200MM X 90CM; 12) AB14W050200150, Size: 5MM X 200MM X 150CM; 13) AB14W060040090, Size: 6MM X 40MM X 90CM; 14) AB14W060040150, Size: 6MM X 40MM X 150CM; 15) AB14W060060150, Size: 6MM X 60MM X 150CM; 16) AB14W060080150, Size: 6MM X 80MM X 150CM; 17) AB14W060100150, Size: 6MM X 100MM X 150CM; 18) AB14W060120150, Size: 6MM X 120MM X 150CM; 19) AB14W060150150, Size: 6MM X 150MM X 150CM; 20) AB14W060200150, Size: 6MM X 200MM X 150CM; Balloon Dilatation Catheter
FDA Recall
Open, Classified
·Product code LIT·December 10, 2024
Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter working length 150cm Component: NA
FDA Recall
Open, Classified
·SUMMA THERAPEUTICS, LLC·Product code LIT·July 21, 2025
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
FDA Recall
Open, Classified
·Covidien Llc·Product code LIT·December 17, 2021
MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code KRR·December 22, 2022
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
FDA Recall
Open, Classified
·Exactech, Inc.·Product code KWT·August 21, 2018
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code HSZ·January 24, 2024
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
FDA Recall
Open, Classified
·Fresenius Kabi USA, LLC·Product code FRN·January 10, 2025
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code HSZ·January 24, 2024
Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBG·April 17, 2024
SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code MJC·July 17, 2025
Ref No: INSHITHND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBG·January 19, 2024
Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBG·January 19, 2024
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBG·October 19, 2023
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code MJC·July 17, 2025
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code MJC·July 17, 2025
KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.
FDA Recall
Open, Classified
·Pro-Dex Inc·Product code GET·February 14, 2023
Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020