13 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059, 722065, 722066, 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. Wireless footswitch Models: 459801319471, 459801319521, 459801319361, 459801319421, 459801319481, 459801319531, 459801319511, 459801319541, 459801319371, 459801319431, 459801319391, 459801319441, 459801238241, 459801238231, 459801238261, 459801238251, 459801238201, 459801238191, 459801238221, 459801238211, 459801733051, 459801733061, 459801733071, 459801733081, 459801257861, 459801733091
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·January 19, 2022
TVS LPA, Catalog #: DIL-059-00
FDA Enforcement
Class II
·Terminated·Galt Medical Corporation·August 8, 2018
SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
FDA Enforcement
Class II
·Ongoing·Cordis Corporation·November 24, 2021
SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
FDA Enforcement
Class II
·Ongoing·Cordis Corporation·November 24, 2021
SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
FDA Enforcement
Class II
·Ongoing·Cordis Corporation·November 24, 2021
SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
FDA Enforcement
Class II
·Ongoing·Cordis Corporation·November 24, 2021
SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
FDA Enforcement
Class II
·Ongoing·Cordis Corporation·November 24, 2021
SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
FDA Enforcement
Class II
·Ongoing·Cordis Corporation·November 24, 2021
AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider.
FDA Enforcement
Class II
·Terminated·Ansh Labs, LLC·January 20, 2021
MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.
FDA Enforcement
Class II
·Terminated·MedtestDx, Inc.·September 23, 2015
Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46
FDA Enforcement
Class II
·Terminated·Galt Medical Corporation·August 8, 2018
1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14; 4) Micro-Access Tearaway Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-010-14; 5) Mini Tear Away Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-027-04; 6) LI-11 Plus G, Sterile EO, Catalog #: KIT-042-11; 7) LI-12 Plus G, Sterile EO, Catalog #: KIT-042-12; 8) Micro-Access Tearaway Introducer Kit, Sterile EO, Catalog #: a) KIT-900-13; b) KIT-900-14; c) KIT-900-17; d) KIT-900-29; e) KIT-901-02; f) KIT-901-02; 9) "Micro-Access" Kit, Sterile EO, Catolog #: KIT-900-88 10) Mini Stick II Microintroducer Kit. Sterile EO, Rx Only, Catalog #: a) KIT-045-05; b) KIT-045-15;
FDA Enforcement
Class II
·Terminated·Galt Medical Corporation·August 8, 2018
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
FDA Enforcement
Class II
·Ongoing·Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.·January 31, 2024