Linvatec Corp.
United StatesFDA applicant, unverified
- Devices
- 93
- FDA recalls
- 56
At a glance
Market reach
- United States
- FDA recalls
What Linvatec Corp. makes
Linvatec Corp. manufactures surgical instruments and systems for minimally invasive procedures, including ablation devices like the Trident Resection Ablator and LightWave Suction Ablators (models EL-2000-S, IA-2000-S, and IA-), as well as tissue morcellation tools such as the CUTO system. The company also produces endoscopic and hysteroscopic devices, including the EndoPearl and EndoPearl with Threader, continuous flow hysteroresectoscopes, and universal drive and irrigation systems. Suturing solutions like the Super Revo Herculine Suture Anchor Washer are part of its portfolio, alongside xenon light sources for surgical illumination.
Linvatec Corp.’s devices are classified under FDA regulations as Class I and Class II, with most requiring 510(k) clearance. The company’s products are listed in the FDA’s 510(k) registry, reflecting their authorised status under U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 93 devicesShowing 1-50 of 93
FDA recalls
FDA recall records list 56 recalls initiated by Linvatec Corp., the earliest on 2004-08-26 and the most recent on 2008-02-21. By recorded status: 56 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 21 Feb 2008 Z-0360-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0361-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0362-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0363-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0364-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0365-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0366-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0367-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0368-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0369-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
Show the 25 most recent of 56 recalls
2008
- 21 Feb 2008 Z-0370-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0371-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0372-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0373-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0374-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0375-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0376-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0377-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0378-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0379-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0380-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0381-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0382-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0383-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
- 21 Feb 2008 Z-0384-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
Frequently asked questions
How many devices does Linvatec Corp. have in the registry?
The registry currently lists 93 devices for Linvatec Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Linvatec Corp.'s devices?
Among its 50 most recently registered devices, Linvatec Corp. has devices listed in FDA 510(k) (50 devices).
What risk classes do Linvatec Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Linvatec Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Linvatec Corp.?
FDA recall records list 56 recalls initiated by Linvatec Corp., the most recent initiated on 2008-02-21. 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 Linvatec Corp. in the registry?
The most recently registered devices listed for Linvatec Corp. include ENDOPEARL, TRIDENT RESECTION ABLATOR, LINVATEC 300W XENON LIGHT SOURCE and CUTO(TM) TISSUE MORCELLATION SYSTEM.