16 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile. Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
FDA Recall
Terminated
·Devicor Medical Products Inc·Product code OIJ·May 19, 2016
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
FDA Recall
Terminated
·Hologic, Inc.·Product code OIJ·July 7, 2017
Chlamydia OIA. For in vitro diagnostic use.
FDA Recall
Terminated
·Thermo Biostar, Incorporated·Product code LJC·February 7, 2003
Chlamydia OIA. For in vitro diagnostic use,
FDA Recall
Terminated
·Thermo Biostar, Incorporated·Product code LJC·February 7, 2003
Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.
FDA Recall
Terminated
·Binax, Inc. dba IMPD·Product code GTZ·April 6, 2009
BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027
FDA Recall
Terminated
·Inverness Medical BioStar Inc.·Product code GNX·July 2, 2008
J-VAC Reservoir is a component of the J-VAC Closed Wound Drainage System. This system is a sterile, portable system used for closed wound drainage. This system is composed of two parts: the J-VAC Reservoir and Suction Drains.
FDA Recall
Terminated
·Ethicon, Inc US·Product code GCY·August 31, 2005
PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath
FDA Enforcement
Class II
·Terminated·Terumo Medical Corporation·September 14, 2016
TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
FDA Enforcement
Class II
·Terminated·Olympus America Inc.·December 11, 2013
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
FDA Recall
Terminated
·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code CIJ·July 10, 2020
TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
FDA Recall
Terminated
·Olympus America Inc.·Product code GEI·September 27, 2013
ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.
FDA Recall
Terminated
·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·February 5, 2018
ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.
FDA Recall
Terminated
·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·November 9, 2011
ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.
FDA Recall
Terminated
·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·November 9, 2011
ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810
FDA Recall
Terminated
·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·February 5, 2018
ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories.
FDA Recall
Terminated
·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·February 5, 2018