36 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
FDA Enforcement
Class II
·Terminated·Biocompatibles U.K., Ltd.·October 19, 2016
TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
FDA Recall
Terminated
·Biocompatibles U.K., Ltd. Bortoli House Weydon Lane; Old Farnham Lane Farnham United Kingdom·Product code NAW·September 21, 2015
ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOB·May 5, 2020
ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 17, 2020
QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·February 18, 2020
MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (¿g Eq/ml) can be determined by comparison to a standard curve.
FDA Enforcement
Class II
·Terminated·Diagnostic Hybrids, Inc.·May 2, 2018
QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
FDA Enforcement
Class II
·Terminated·Microbiologics Inc·February 16, 2022
MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (g Eq/ml) can be determined by comparison to a standard curve.
FDA Recall
Terminated
·Diagnostic Hybrids, Inc.·Product code DAK·April 4, 2017
Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures
FDA Recall
Terminated
·Ethicon, Inc. Us·Product code GAQ·April 19, 2019
Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.
FDA Recall
Terminated
·Teleflex Medical·Product code GAQ·March 11, 2014
ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code GBQ·June 29, 2015
Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures
FDA Recall
Terminated
·Ethicon, Inc. Us·Product code GAQ·April 19, 2019
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
FDA Recall
Terminated
·Teleflex Medical·Product code GAQ·March 11, 2014
Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016