Rexton, Inc.
Mchenry, IL, US
Rexton, Inc. appears in FDA device records in Mchenry, IL. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Rexton, Inc. between 1983 and 1997. The busiest year on record is 1990, with 4. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1986 | 1 |
| 1989 | 2 |
| 1990 | 4 |
| 1992 | 2 |
| 1994 | 4 |
| 1995 | 3 |
| 1996 | 3 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K970537 | REXTON MODEL 48 AND 49PP | ESD | Substantially Equivalent | |
| K964451 | PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC | ESD | Substantially Equivalent | |
| K960295 | LONG LIFE RX-12 | ESD | Substantially Equivalent | |
| K954922 | REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS | ESD | Substantially Equivalent | |
| K953770 | REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY | ESD | Substantially Equivalent | |
| K950451 | M-29 PP-PC, M-29 PP-O/PC | ESD | Substantially Equivalent | |
| K944851 | MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC | ESD | Substantially Equivalent | |
| K944777 | ORION PPM, PP, PP-D | ESD | Substantially Equivalent | |
| K944359 | EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12 | ESD | Substantially Equivalent | |
| K942702 | DEEP CANAL HEARING INSTRUMENT | ESD | Substantially Equivalent | |
| K944548 | REXPLUS PP3 | ESD | Substantially Equivalent | |
| K915684 | REXTON RX34 WITH HORIZON PROGRAMMABLE OPTION | ESD | Substantially Equivalent | |
| K915683 | REXTON RX12 WITH HORIZON PROGRAMMABLE OPTION | ESD | Substantially Equivalent | |
| K901341 | REXTON RX12 POWER PLUS W/DUAL RECEIVER | ESD | Substantially Equivalent | |
| K900636 | REXTON PP 142, PP 142-L | ESD | Substantially Equivalent | |
| K896057 | MINI PRIMO PLUS ASP BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K896056 | REXTON RX12D CUSTOM IN-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K892898 | ASTRO BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K892333 | REXTON RX12PP, RX20PP & RX34PP IN-THE-EAR HEAR AID | ESD | Substantially Equivalent | |
| K861532 | RX-33S INTRA MINI CANAL MODULE | ESD | Substantially Equivalent | |
| K832180 | REXTON RX10, RX20-30 & 40 | ESD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
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 Rexton, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Rexton, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain