E-Z-Em, Inc.
United StatesFDA 510(k) applicant, unverified FDA FEI 2411512
- Devices
- 56
- Registrations
- FDA
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What E-Z-Em, Inc. makes
E-Z-Em, Inc. manufactures a range of single-use medical devices for procedural and diagnostic applications, including enteric drainage tubes with guide wires, biopsy needles for soft tissue and Lufkin core sampling, puncture/drainage systems, winged infusion sets, bronchial cytology brushes, angiography needles, cystoscopy aids, vascular fluid management systems, bloodless needle devices, automated injector systems, vacuum aspiration syringes, and various biopsy needle designs.
The company’s products are regulated under FDA classifications spanning Class I, Class II, Class III, and unclassified (U) devices, with many authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Search and filter all 56 devicesShowing 1-50 of 56
Company details
- FDA FEI number
- 2411512
- Address
- 510 Carnegie Center, Princeton, NJ, 08540
FDA recalls
FDA recall records list 3 recalls initiated by E-Z-Em, Inc., initiated on 2004-12-03. By recorded status: 3 terminated. The reasons filed fall into these groups: mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 3 Dec 2004 Z-0548-05 Unclassified (pre-2012) Terminated Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.
Full distribution text
- 3 Dec 2004 Z-0549-05 Unclassified (pre-2012) Terminated Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.
Full distribution text
- 3 Dec 2004 Z-0550-05 Unclassified (pre-2012) Terminated Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.
Full distribution text
- 3 Dec 2004 Z-0548-05 Unclassified (pre-2012) Terminated Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.
Frequently asked questions
How many devices does E-Z-Em, Inc. have in the registry?
The registry currently lists 56 devices for E-Z-Em, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list E-Z-Em, Inc.'s devices?
Among its 50 most recently registered devices, E-Z-Em, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do E-Z-Em, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for E-Z-Em, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for E-Z-Em, Inc.?
FDA recall records list 3 recalls initiated by E-Z-Em, Inc., the most recent initiated on 2004-12-03. 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 E-Z-Em, Inc. in the registry?
The most recently registered devices listed for E-Z-Em, Inc. include ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT, E-Z-EM(R) LUFKIN BIOPSY NEEDLES, E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE and WINGED INFUSION SET.