57 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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DAC 044 115cm, Catalog: 90760
FDA Enforcement
Class II
·Ongoing·Stryker Neurovascular·June 5, 2024
AXIOM Artis dBC, Model Number 5917054
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
AXIOM Artis dBC, Model Number 7728392
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each catheter. The rotating hemostasis valve is typically y shaped with a female luer lock and a manual hemostasis valve. The female port allows for aspiration and contrast injections while the hemostasis valve allows direct arterial access when using other devices such as guidewires and/or interventional devices.
FDA Enforcement
Class II
·Ongoing·Stryker Neurovascular·May 8, 2024
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART.
FDA Enforcement
Class I
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 16, 2025
CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
FDA Enforcement
Class II
·Terminated·Graphic Controls Acquisition Corporation·April 20, 2022
CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
FDA Enforcement
Class II
·Terminated·Graphic Controls Acquisition Corporation·April 20, 2022
CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
FDA Enforcement
Class II
·Terminated·Graphic Controls Acquisition Corporation·April 20, 2022
CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US
FDA Enforcement
Class II
·Terminated·Graphic Controls Acquisition Corporation·April 20, 2022
CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
FDA Enforcement
Class II
·Terminated·Graphic Controls Acquisition Corporation·April 20, 2022
CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
FDA Enforcement
Class II
·Terminated·Graphic Controls Acquisition Corporation·April 20, 2022
Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX Uncut Sheet-Card/ 187877, 160130/ EDI COC Uncut Sheet-Cup/ 188168, 160180/ EDI PCP Uncut Sheet-Cup/ 189027, 160140/ EDI THC Uncut Sheet Cup /189028, 160170/ EDI BZO Uncut Sheet-Cup/ 189081, 160120/ EDI MET1000 Uncut Sheet-Cup/ 189082, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189123, 160130/ EDI COC Uncut Sheet-Cup/ 189124, 160160/ EDI OPI2000 Uncut Sheet-Cup/ 189166, 160163/ EDI OPI (300) Uncut Sheet-Cup/ 189191, 160110/ EDI AMP Uncut Sheet-Cup/ 189371, 160140/ EDI THC Uncut Sheet Cup/ 189372, 160123/ EDI MET(300) Uncut Sheet-Cup/ 189425, 160170/ EDI BZO Uncut Sheet-Cup/ 189426, 100163/ EDI OPI (300) Uncut Sheet-Card/ 189456, 160170/ EDI BZO Uncut Sheet-Cup/ 189565, 160180/ EDI PCP Uncut Sheet-Cup/ 189601, 160125/ EDI MET(500) Uncut Sheet-Cup/ 189748, 160130/ EDI COC Uncut Sheet-Cup/ 189786, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189844, 160180/ EDI PCP Uncut Sheet-Cup/ 189937, 160172/ EDI BZO(200) Uncut Sheet-CUP/189956 Updated 09/03/2020: EDI Affected products -Catalog Numbers/ Lot Numbers 31105-3/ PI-01081 60503s-3ZC/ PH-10132 60600/ PH-11005
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 7, 2020
Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM Artis FA 05904441; AXIOM Artis MP 05904466; AXIOM Artis BC 05904649; AXIOM Artis BA 05904656; AXIOM Artis dBC Mag. Nav. 05917054; AXIOM Artis TA 07007755; AXIOM Artis dTA 07008605; AXIOM Artis dFC 07412807; AXIOM Artis dTC 07413078; AXIOM Artis dBA 07555357; AXIOM Artis dMP 07555365; AXIOM Artis dFA 07555373; AXIOM Artis dFC Mag. Nav. 07727717; AXIOM Artis TC 07728350; AXIOM Artis dBC 07728392; Artis zee floor 10094135; Artis zee ceiling 10094137; Artis zee MP 10094139; Artis zee biplane 10094141; Artis zee floor MN 10094142; Artis zee biplane MN 10094143; Artis Q floor 10848280; Artis Q ceiling 10848281; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen ceiling 10848354; Artis Q.zen biplane 10848355.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·May 5, 2021
Radiography 7300 C; Model Number: 712037;
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
EasyDiagnost Eleva DRF (Stitching Patient Support) 706032
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost Single Detector (Stitching Patient Support) 712020
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
CombiDiagnost R90 (Stitching Patient Support) 709030
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018