Symbiosis Corp.
United StatesFDA applicant, unverified
- Devices
- 34
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
What Symbiosis Corp. makes
Symbiosis Corp. manufactures biopsy forceps for gastrointestinal, urological, pulmonary, and gynecological applications, including both reusable and disposable versions with reusable handles. The company also produces suction-irrigators, monopolar and bipolar electrosurgical probes, thoracentesis systems, arthroscopic surgical instruments, manual general surgical instruments, and aspiration needles for sternal or iliac use.
The devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry. Symbiosis Corp. is based in the United States.
Catalogue
Search and filter all 34 devicesFDA recalls
FDA recall records list 6 recalls initiated by Symbiosis Corp., the earliest on 2002-07-16 and the most recent on 2002-11-27. By recorded status: 6 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2002
- 27 Nov 2002 Z-0666-03 Unclassified (pre-2012) Terminated The 180 cm guidewire is mislabeled as 260 cm and the 260 cm guidewire is mislabeled as 180 cm.
- 19 Nov 2002 Z-0592-03 Unclassified (pre-2012) Terminated Product is mislabled as a ChoICE Floppy Guide Wire when it is actually a ChoICE ES(Extra Support) Guide Wire.
- 3 Sep 2002 Z-0562-03 Unclassified (pre-2012) Terminated Product does not have the needle component as part of the jaw assembly.
- 22 Aug 2002 Z-0590-03 Unclassified (pre-2012) Terminated Product labeled as Scimed ChoICE PT Extra Suport PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm
- 22 Aug 2002 Z-0591-03 Unclassified (pre-2012) Terminated Product labeled as Scimed ChoICE PT Extra Suport PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm
- 16 Jul 2002 Z-0589-03 Unclassified (pre-2012) Terminated Labeled as J tip but may be straight tip.
Frequently asked questions
How many devices does Symbiosis Corp. have in the registry?
The registry currently lists 34 devices for Symbiosis Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Symbiosis Corp.'s devices?
Among its 34 most recently registered devices, Symbiosis Corp. has devices listed in FDA 510(k) (34 devices).
What risk classes do Symbiosis Corp.'s devices fall under?
Among its 34 most recently registered devices, the classes recorded for Symbiosis Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Symbiosis Corp.?
FDA recall records list 6 recalls initiated by Symbiosis Corp., the most recent initiated on 27 Nov 2002. 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 Symbiosis Corp. in the registry?
The most recently registered devices listed for Symbiosis Corp. include HOT BIOPSY FORCEPS, SYMBIOSIS SUCTION-IRRIGATOR, SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE and SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS.