Viscot Medical LLC
East Hanover, NJ, US
VISCOT MEDICAL LLC appears in FDA device records in East Hanover, NJ. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2242656 | 2242656 | VISCOT MEDICAL LLC | 5 Stewart Ct, Denville, NJ 07834 US | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FMHContainer, Specimen, Sterile
- GDIDissector, Surgical, General & Plastic Surgery
- KBMDissector, Tonsil
- PUIDrape, Surgical, Exempt
- FRLFiber, Medical, Absorbent
- EFQGauze/Sponge, Internal
- GDYGauze/Sponge, Internal, X-Ray Detectable
- QMXLabel Or Tag, Non-Sterile
- LYVLabel Or Tag, Sterile
- HMRMarker, Ocular
- FZZMarker, Skin
- HRPPen, Marking, Surgical
- HOZSponge, Ophthalmic
- FTYTape, Measuring, Rulers And Calipers
- LRPTray, Surgical
- FNPUrinal
- FRGWrap, Sterilization
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1025-2013 | Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking. | Dual Tip Marker has inconsistent ink flow on the black permanent ink side. | Class III | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Viscot Medical LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain