Zipline Medical, Inc.
Country not established
- Devices
- 12
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Zipline Medical, Inc. makes
ZipLine Medical, Inc. manufactures the Zip 4 Skin Closure Device, a medical device designed for wound closure in surgical procedures. This product is intended for use in minimally invasive procedures to approximate skin edges without sutures or staples, reducing post-operative complications and improving patient recovery.
The Zip 4 Skin Closure Device is classified as a Class I medical device under FDA regulations and has undergone the 510(k) clearance process. The company is based in the United States, where its product is listed for commercial distribution and use.
Catalogue
Search and filter all 12 devicesCompany details
- DUNS number
- 962534124
- [email protected]
- Phone
- 888-326-8999
FDA recalls
FDA recall records list 3 recalls initiated by ZIPLINE MEDICAL, INC., initiated on 2015-02-05. By recorded status: 3 terminated. The reasons filed fall into these groups: sterility or contamination, packaging 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.
2015
- 5 Feb 2015 Z-1234-2015 Class II Terminated The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
Full distribution text
- 5 Feb 2015 Z-1235-2015 Class II Terminated The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
Full distribution text
- 5 Feb 2015 Z-1236-2015 Class II Terminated The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
Full distribution text
- 5 Feb 2015 Z-1234-2015 Class II Terminated The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
Frequently asked questions
How many devices does ZIPLINE MEDICAL, INC. have in the registry?
The registry currently lists 12 devices for ZIPLINE MEDICAL, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ZIPLINE MEDICAL, INC.'s devices?
Among its 12 most recently registered devices, ZIPLINE MEDICAL, INC. has devices listed in FDA 510(k) (1 device) and FDA GUDID (11 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ZIPLINE MEDICAL, INC.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for ZIPLINE MEDICAL, INC.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for ZIPLINE MEDICAL, INC.?
FDA recall records list 3 recalls initiated by ZIPLINE MEDICAL, INC., the most recent initiated on 2015-02-05. 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 ZIPLINE MEDICAL, INC. in the registry?
The most recently registered devices listed for ZIPLINE MEDICAL, INC. include Zip 24 Surgical Skin Closure Device 667616001, Zip 16 Surgical Skin Closure Device PS1160, Zip 4 Surgical Skin Closure Device 667613001 and Zip 24 Surgical Skin Closure Device 900024001.