18 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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DAC 044 115cm, Catalog: 90760
FDA Recall
Open, Classified
·Stryker Neurovascular·Product code DQY·April 23, 2024
PDSIIVIO30IN(75CM)USP6-0(M0.7)D/AC-1
FDA Recall
Open, Classified
·Ethicon Endo Surgery, LLC·Product code NEW·March 7, 2025
PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
FDA Recall
Open, Classified
·Ethicon Endo Surgery, LLC·Product code NEW·March 7, 2025
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 Recall
Open, Classified
·Stryker Neurovascular·Product code DQY·April 3, 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 Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·February 21, 2025
Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic response study.
FDA Recall
Open, Classified
·Vyaire Medical, Inc. Leibnizstr. 7 Hochberg Germany·Product code BZC·April 8, 2024
CombiDiagnost R90; Model Number: 709031;
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·October 1, 2025
DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code KPR·October 1, 2025
Radiography 7300 C; Model Number: 712037;
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code KPR·October 1, 2025
ProxiDiagnost N90; Model Number: 706110;
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·October 1, 2025
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code MQB·October 1, 2025
Precision CRF; Model Number: 706400;
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·October 1, 2025
ProxiDiagnost N90. radiography and fluoroscopy system
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code JAA·May 19, 2021
CombiDiagnost R90 Software Version R1.0 and R1.1
FDA Recall
Open, Classified
·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code JAA·July 22, 2020
DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code KPR·May 19, 2021
DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code KPR·May 19, 2021
DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code KPR·May 19, 2021
DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code KPR·May 19, 2021