# Coeur, Inc.

- Location (FDA's records): Lebanon, TN
- FDA decisions: 14 (2005–2017): 14 510(k) clearances
- Product codes: DXT (10), DQX (1), DTL (1), DQO (1), FPK (1)
- Predicates its devices cite: 40 (6 its own); citations of its devices by later devices: 12 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medrad, Inc.: 10 (https://510kreport.com/company/medrad)
- Coeur Laboratories, Inc.: 7 (https://510kreport.com/company/coeur-laboratories)
- Mallinckrodt Inc., Liebel-Flarsheim Business: 3 (https://510kreport.com/company/mallinckrodt-liebel-flarsheim-business)
- Mallinckrodt Group, Inc.: 2 (https://510kreport.com/company/mallinckrodt-group)
- E-Z-Em, Inc.: 2 (https://510kreport.com/company/e-z-em)
- Sherwood Medical Co.: 1 (https://510kreport.com/company/sherwood-medical)
- Shenzhen Ant Hi-Tech Industrial Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-ant-hi-tech-industrial)
- Unimachs Corp.: 1 (https://510kreport.com/company/unimachs)

## Firms that cite its devices most
- Nemoto Kyorindo Co., Ltd.: 3 (https://510kreport.com/company/nemoto-kyorindo)
- Shenzhen Ant Hi-Tech Industrial Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-ant-hi-tech-industrial)
- Sunny Medical Device (Shenzhen) Co., Ltd.: 1 (https://510kreport.com/company/sunny-medical-device-shenzhen)

## Its most-cited devices
- K051799: Disposable CT/MR Syringes for Nemoto Injectors (2005), cited by 4
- K120892: Disposable 330PSI Extension Lines (2013), cited by 2
- K071196: Disposable High Pressure Injection Lines with and Without Rotating Adapters (2007), cited by 2
- K070798: Adapters for CT, Angiographic, and/or Mri Power Injectors (2007), cited by 2
- K161471: MR Syringe Dual Pack for Solaris Injectors (2016), cited by 1
- K090487: Disposable Angiographic Syringes for Use with Nemoto Angiographic Power, Model SY-125, C855-5150 (2009), cited by 1

## Recent decisions
- K170431: CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip (Aug 18, 2017)
- K161471: MR Syringe Dual Pack for Solaris Injectors (Oct 6, 2016)
- K150902: 330psi Extension Y-Line with Dual Check Valve (Oct 22, 2015)
- K142745: 125mL CT Syringe (Apr 1, 2015)
- K140469: MR Syringe Dual Pack (Jul 28, 2014)
- K133600: Coeur, Inc. Frontload for Optivantage Power Injector (Apr 30, 2014)
- K120892: Disposable 330PSI Extension Lines (Jun 10, 2013)
- K113498: Disposable Torque Device (Jul 20, 2012)

Source page: https://510kreport.com/company/coeur