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Best Precision Stabilizer

Best Nomos · Model 6000 · UDI-DI 00852656007472

IWJ
10
510(k) clearances
165
Adverse events
11
Recalls
46
Facilities

Description

The Precision Stabilizer consists of one Trigger Head and two Stabilizer Arms.The Precision Stabilizer is intended to provide a platform for devices that need a support mechanism in 3D space and it allows for 6-degrees of freedom to position the device in 3D space. One of it's intended uses is to provide a platform for use of an ultrasound transducer.

Recalls

DateFirmReason
2021-02-22Sirtex Medical LimitedThere is a potential presence of particulate matter in the D-Vial.
2019-02-08Riverpoint Medical, LLCThe integrity of the sterile grid packaging is potentially compromised.
2018-10-09Theragenics CorporationSome of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
2018-01-09Riverpoint Medical, LLCProduct is labeled with "CE", but is not yet approved in the European Union.
2011-08-12Worldwide Medical Technologies, LLCLength of the cannula hub is longer and may not permit a fit with the Applicator
2009-09-01Medical Device Technologies, Inc.Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone B
2007-11-15Alpha Omega Services IncThere is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contamin
2007-11-15Alpha Omega Services IncThere is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contamin
2007-11-15Alpha Omega Services IncThere is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contamin
2007-11-15Alpha Omega Services IncThere is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contamin

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.