Harvest Technologies, Corp.
United StatesFDA applicant, unverified
- Devices
- 9
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Harvest Technologies, Corp. makes
Harvest Technologies manufactures systems and applicators for processing and delivering bone graft materials, adipose tissue, and platelet concentrates. Their portfolio includes liquid applicators for bone grafts, centrifuges for preparing bone marrow aspirate concentrate (BMAC), and systems for adipose tissue transfer. These devices are designed to streamline tissue processing and enhance delivery precision in surgical applications.
The company’s products are regulated under FDA’s Class I and Class II categories, with several devices authorised via the 510(k) pathway. They are listed in the FDA’s 510(k) database, and the company is based in the United States.
Catalogue
Smartprep Centrifuge System Ref K991430
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
SMARTPREP2 Centrifuge System Ref K052925
Regimes: 510(k) Registry: 510(k)Adiprep Adipose Transfer System Ref K121005
Regimes: 510(k) Registry: 510(k)Smartcell Processing System Ref K983022
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Harvest Technologies Dual Liquid Applicator, Model Sk/S: Harvest Dual Liquid Applicator Lk/2 Ref K000456
Regimes: 510(k) Registry: 510(k)Harvest Graft Delivery Syringe Ref K043261
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Harvest Technologies, Corp., initiated on 2013-09-11. By recorded status: 1 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.
2013
- 11 Sep 2013 Z-0022-2014 Class II Terminated Potential for leur connector to leak or have cracks.
Full distribution text
- 11 Sep 2013 Z-0022-2014 Class II Terminated Potential for leur connector to leak or have cracks.
Frequently asked questions
How many devices does Harvest Technologies, Corp. have in the registry?
The registry currently lists 9 devices for Harvest Technologies, Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Harvest Technologies, Corp.'s devices?
Among its 9 most recently registered devices, Harvest Technologies, Corp. has devices listed in FDA 510(k) (9 devices).
What risk classes do Harvest Technologies, Corp.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Harvest Technologies, Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Harvest Technologies, Corp.?
FDA recall records list 1 recall initiated by Harvest Technologies, Corp., the most recent initiated on 11 Sep 2013. 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 Harvest Technologies, Corp. in the registry?
The most recently registered devices listed for Harvest Technologies, Corp. include SMARTPREP CENTRIFUGE SYSTEM, SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA, SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 and SMARTPREP2 CENTRIFUGE SYSTEM.