North Coast Medi-Tek
Eastlake, OH, US
North Coast Medi-Tek appears in FDA device records in Eastlake, OH. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for North Coast Medi-Tek between 1985 and 1987. The busiest year on record is 1987, with 5. The most recent is 1987, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1987 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K870419 | IVR-SP CUSTOM ANGIOGRAPHY TRAY | DQO | Substantially Equivalent | |
| K870420 | PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY | GBZ | Unknown | |
| K870416 | LP EXTENSION SETS | FPK | Substantially Equivalent | |
| K870418 | MYA-1 AND MYT-1 MYELOGRAM TRAY | Substantially Equivalent | ||
| K870417 | RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY | FSM | Substantially Equivalent | |
| K854095 | BIOPSY TRAY I & II | LRO | Unknown |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2982-2011 | Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case. Sterile, Disposable Convenience Kits used for diagnostic radiology procedures. A diagnostic radiology kit used in CT and general biopsies | During routine bioburden testing, unusually high results were found for a Bioburden Test done on 4/19/11. Bioburden Level reported as >150,000 CFU. Our Alert Level is 17,000 CFU and the Action Level is 23,000 CFU. | Terminated | ||
| Z-1571-05 | Ultrasound probe cover, sterile. Catalog No. 910811. | Customer observed unsealed packages. | Terminated | ||
| Z-1572-05 | SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case. | Outside box labeling, containing 10 trays, incorrectly identified the product as ultrasound trays. Product is Breast Biopsy trays, Cat. 255826R2. Individual tray package labeling correctly identifies the product as Breast Biopsy tray. | Terminated | ||
| Z-1523-05 | E-Z-EM brand, Basic biopsy tray, catalog no. 4125. | Product contains the incorrect lot number. | 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 North Coast Medi-Tek 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