Ballard Medical Products
Country not established
- Devices
- 26
- FDA recalls
- 7
At a glance
Market reach
- United States
- FDA recalls
What Ballard Medical Products makes
Ballard Medical Products manufactures airway management and respiratory support devices, including suction catheters, tracheostomy care kits, and reusable bronchial biopsy forceps. Their portfolio also includes gastric lavage kits, paracentesis trays and needles, and Heimlich valve systems for airway pressure applications. Electrosurgical tools and specialized needles for medical procedures are part of their product line.
The company’s devices are classified under FDA categories Class I and Class II, with many authorised through the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Search and filter all 26 devicesFDA recalls
FDA recall records list 7 recalls initiated by Ballard Medical Products, initiated on 2003-06-13. By recorded status: 7 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2003
- 13 Jun 2003 Z-1079-03 Unclassified (pre-2012) Terminated Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
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- 13 Jun 2003 Z-1080-03 Unclassified (pre-2012) Terminated Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
Full distribution text
- 13 Jun 2003 Z-1081-03 Unclassified (pre-2012) Terminated Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
Full distribution text
- 13 Jun 2003 Z-1082-03 Unclassified (pre-2012) Terminated Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
Full distribution text
- 13 Jun 2003 Z-1083-03 Unclassified (pre-2012) Terminated Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
Full distribution text
- 13 Jun 2003 Z-1084-03 Unclassified (pre-2012) Terminated Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
Full distribution text
- 13 Jun 2003 Z-1085-03 Unclassified (pre-2012) Terminated Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
Full distribution text
- 13 Jun 2003 Z-1079-03 Unclassified (pre-2012) Terminated Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
Frequently asked questions
How many devices does Ballard Medical Products have in the registry?
The registry currently lists 26 devices for Ballard Medical Products. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ballard Medical Products's devices?
Among its 26 most recently registered devices, Ballard Medical Products has devices listed in FDA 510(k) (26 devices).
What risk classes do Ballard Medical Products's devices fall under?
Among its 26 most recently registered devices, the classes recorded for Ballard Medical Products's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ballard Medical Products?
FDA recall records list 7 recalls initiated by Ballard Medical Products, the most recent initiated on 13 Jun 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Ballard Medical Products in the registry?
The most recently registered devices listed for Ballard Medical Products include SAFETY SHIELD SUCTION CATHETER, SAFETY SHIELD KIT, REUSABLE BRONCHIAL BIOPSY FORCEPS and TRACH CARE START KIT.