96 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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BD Vacutainer Specimen Collection Cups, Cat. No. 364975
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JTW·August 30, 2018
KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JTW·August 30, 2018
KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JTW·August 30, 2018
BD Vacutainer Urine Collection Cups, Cat. No. 364941
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JTW·August 30, 2018
BD Vacutainer Urine Collection Cups, Cat. No. 364941
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·November 28, 2018
BD Vacutainer Specimen Collection Cups, Cat. No. 364975
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·November 28, 2018
HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 15, 2017
KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·November 28, 2018
KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·November 28, 2018
HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code FMF·October 20, 2017
High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code GCP·April 19, 2017
A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code GCP·August 18, 2017
ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.
FDA Enforcement
Class II
·Terminated·Horiba Instruments, Inc dba Horiba Medical·July 4, 2018
ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.
FDA Recall
Terminated
·Horiba Instruments, Inc dba Horiba Medical·Product code PFT·April 26, 2018
Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.
FDA Enforcement
Class II
·Terminated·C P Medical, Inc.·November 5, 2014
VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS Chemistry Products AcP Slides quantitatively measure acid phosphatase (AcP) activity in serum and plasma using VITROS 950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·November 27, 2013
Cardiovascular Custom Procedure Kits, Rev O X-Coated 8:1 CP No OXY Item Number: 73329 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011
Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.
FDA Recall
Terminated
·C P Medical, Inc.·Product code NEW·September 22, 2014
life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage 12V, 7.5 amps; Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.
FDA Recall
Terminated
·Exocomm Tech Grp·Product code MKJ·September 3, 2007
life+cel, Replacement battery for Cardiac Science FirstSave Survivalink; OEM P/N:9141-001, Part #: 2L561, Lithium Sulfur Dioxide, Voltage 12V, 7.5 amps., Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.
FDA Recall
Terminated
·Exocomm Tech Grp·Product code MKJ·September 3, 2007