Meadox Surgimed, Inc.
Mchenry, IL, US
Meadox Surgimed, Inc. appears in FDA device records in Mchenry, IL. FDA records list 24 510(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
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Meadox Surgimed, Inc. between 1984 and 1995. The busiest year on record is 1985, with 5. The most recent is 1995, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 2 |
| 1985 | 5 |
| 1986 | 5 |
| 1987 | 2 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 4 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K944143 | MS CLASSIQUE BALLOON CATHETER | FGE | Substantially Equivalent | |
| K945061 | NOPROFILE OLBERT CATHETER SYSTEM | KOD | Substantially Equivalent | |
| K942382 | MS AMPLATZ EXTRA STIFF GUIDE WIRE | DQX | Substantially Equivalent | |
| K930201 | ACECUT SUTOMATIC BIOPSY SYSTEM | KNW | Substantially Equivalent | |
| K911635 | MEADOX(R) SURGIMED(R) BIOPSY GUN II | KNW | Substantially Equivalent | |
| K905181 | NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY | EZN | Substantially Equivalent | |
| K904582 | QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE | DQX | Substantially Equivalent | |
| K904983 | MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY | EZN | Substantially Equivalent | |
| K902461 | MEADOX SURGIMED BIOPSY GUN AND NEEDLE | KNW | Substantially Equivalent | |
| K890926 | SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE | FMI | Substantially Equivalent | |
| K863218 | CYTOSTATIC FILTRATION SET | LFK | Substantially Equivalent | |
| K861267 | UROCUT BIOPSY NEEDLE | KNW | Substantially Equivalent | |
| K862742 | NEPHROSTOMY SET | LJE | Substantially Equivalent | |
| K862550 | OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE | LIT | Substantially Equivalent | |
| K860430 | THE NAVIGATOR STEERABLE GUIDE WIRE | DQX | Substantially Equivalent | |
| K861220 | LUNDERQUIST - RING PTC DRAINAGE CATHETER | FGE | Substantially Equivalent | |
| K860429 | MEADOX SURGIMED GUIDE CATHETER | DQO | Substantially Equivalent | |
| K854262 | MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY | FZX | Substantially Equivalent | |
| K854404 | ROTEX SCREW BIOPSY NEEDLE | FCG | Substantially Equivalent | |
| K854420 | MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL | GDM | Substantially Equivalent | |
| K851647 | OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO | FGE | Substantially Equivalent | |
| K851463 | OLBERT CATHETER SYS FOR URETERAL DILATION | EZN | Substantially Equivalent | |
| K843798 | MEADOX SURGIMED A/S CATHETER SHEATH SYS | DYB | Substantially Equivalent | |
| K841704 | THINWALL PUNCTURE NEEDLE | FMI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FCGBiopsy Needle
- LITCatheter, Angioplasty, Peripheral, Transluminal
- LFKCatheter, Femoral
- DQOCatheter, Intravascular, Diagnostic
- LJECatheter, Nephrostomy
- KODCatheter, Urological
- EZNDilator, Catheter, Ureteral
- FZXGuide, Surgical, Instrument
- KNWInstrument, Biopsy
- DYBIntroducer, Catheter
- GDMNeedle, Aspiration And Injection, Reusable
- FMINeedle, Hypodermic, Single Lumen
- FGEStents, Drains And Dilators For The Biliary Ducts
- DQXWire, Guide, Catheter
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.
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Data as of , FDA export datePage updated Source: openFDA, public domain