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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

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

DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

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

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

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

DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015

CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015

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

12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).

FDA Recall
Terminated ·Medical Information Technology, Inc.·Product code JQP·February 21, 2014

12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015