77 results
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Sources: EU EUDAMED, US FDA
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FDA Recall
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SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
FDA Recall
Terminated
·Highland Metals, Inc.·Product code DZC·December 13, 2013
SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
FDA Recall
Terminated
·Highland Metals, Inc.·Product code DZC·December 13, 2013
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
FDA Recall
Terminated
·Ormco/Sybronendo·Product code DZC·November 4, 2015
TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended Use: The intended use of this device is an archwire during orthodontic treatment.
FDA Recall
Terminated
·Ormco Corporation·Product code DZC·March 15, 2011
Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.
FDA Recall
Terminated
·Concentric Medical Inc·Product code DQY·August 19, 2015
DAC 044 115cm, Catalog: 90760
FDA Recall
Open, Classified
·Stryker Neurovascular·Product code DQY·April 23, 2024
AXIOM Artis dBC, Model Number 5917054
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
AXIOM Artis dBC, Model Number 7728392
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
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
Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZI·September 2, 2008
Axiom Artis dBC-M, Axiom Artis Modular Angiography X-Ray System, Model number 5917054.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZI·September 2, 2008
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
CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
FDA Recall
Terminated
·Graphic Controls Acquisition Corporation·Product code DRX·March 15, 2022
CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
FDA Recall
Terminated
·Graphic Controls Acquisition Corporation·Product code DRX·March 15, 2022
CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
FDA Recall
Terminated
·Graphic Controls Acquisition Corporation·Product code DRX·March 15, 2022
CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
FDA Recall
Terminated
·Graphic Controls Acquisition Corporation·Product code DRX·March 15, 2022
CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US
FDA Recall
Terminated
·Graphic Controls Acquisition Corporation·Product code DRX·March 15, 2022
CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
FDA Recall
Terminated
·Graphic Controls Acquisition Corporation·Product code DRX·March 15, 2022