Meadox Medicals, Div. Boston Scientific Corp.
Mchenry, IL, US
Meadox Medicals, Div. Boston Scientific Corp. appears in FDA device records in Mchenry, IL. FDA records list 53 510(k) clearances between and , one PMA record and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 53
- PMA records
- 1
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 53FDA records hold 53 510(k) clearances for Meadox Medicals, Div. Boston Scientific Corp. between 1976 and 1997. The busiest year on record is 1995, with 8. The most recent is 1997, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 5 |
| 1977 | 1 |
| 1981 | 4 |
| 1982 | 1 |
| 1983 | 2 |
| 1985 | 1 |
| 1986 | 2 |
| 1988 | 1 |
| 1991 | 3 |
| 1992 | 3 |
| 1993 | 6 |
| 1994 | 6 |
| 1995 | 8 |
| 1996 | 6 |
| 1997 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K953647 | MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING | LIT | Substantially Equivalent | |
| K960766 | MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT | DYF | Substantially Equivalent - Subject to Tracking Reg. | |
| K962433 | MEADOX EXXCEL EPTFE VASCULAR GRAFT | DSY | Substantially Equivalent - Subject to Tracking Reg. | |
| K961847 | HEMASHIELD VANTAGE (VASCULAR GRAFT | DSY | Substantially Equivalent - Subject to Tracking Reg. | |
| K962342 | HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH | DXZ | Substantially Equivalent | |
| K955460 | MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT | DSY | Substantially Equivalent - Subject to Tracking Reg. | |
| K952884 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | |
| K955349 | HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC | DXZ | Substantially Equivalent | |
| K953298 | MS CLASSIQUE BALLOON DIATATION CATHETER | LIT | Substantially Equivalent | |
| K954848 | HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT | MAL | Substantially Equivalent - Subject to Tracking Reg. | |
| K953608 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | |
| K953691 | MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING | EZN | Substantially Equivalent | |
| K953597 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER | EZN | Substantially Equivalent | |
| K953332 | MS CLASSIQUE BALLOON DILATATION CAHTETER | FGE | Substantially Equivalent | |
| K952887 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER | LJE | Substantially Equivalent | |
| K943358 | NAVIGUIDE HYDROPHILIC GUIDE WIRE | DQX | Substantially Equivalent | |
| K944989 | NOPROFILE OLBERT CATHETER SYSTEM | LIT | Substantially Equivalent | |
| K945576 | MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R) | EZN | Substantially Equivalent | |
| K945377 | TRELEX NATURAL(R) MESH | FTL | Substantially Equivalent | |
| K942635 | MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM | LIT | Substantially Equivalent | |
| K942293 | MS CLASSIQUE BALLOON CATHETER | LIT | Substantially Equivalent | |
| K943298 | MS CLASSIQUE BALLOON CATHETER | LIT | Substantially Equivalent | |
| K936226 | SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET | KDC | Substantially Equivalent | |
| K934411 | MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE | LIT | Substantially Equivalent | |
| K933975 | MEADOX SURGIMED DISPOSABLE PRESSURE GUAGE FOR USE WITH THE OLBERT CATHETER SYSTEM | LIT | Substantially Equivalent | |
| K923947 | MEADOX SURGIMED BALLOON CATHETER | LIT | Substantially Equivalent | |
| K930227 | MS DISPOSABLE RIGID DOPPLER PROBE | DPW | Substantially Equivalent | |
| K931386 | HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC | DXZ | Unknown | |
| K921706 | MEADOX(R) SURGIMED OLBERT CATHETER SYSTEM(R) | LIT | Substantially Equivalent | |
| K930622 | AMPLATZ GUIDEWIRES | DQX | Substantially Equivalent | |
| K922674 | NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE | DQX | Substantially Equivalent | |
| K924749 | TRELEX MESH | FTL | Substantially Equivalent | |
| K922879 | MEADOX SURGIMED BIOPSY GUN III | KNW | Substantially Equivalent | |
| K912798 | AMPLANTZ AND BENTSON GUIDEWIRES | DQX | Substantially Equivalent | |
| K904410 | MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM) | LIT | Substantially Equivalent | |
| K905496 | WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS | DXZ | Substantially Equivalent | |
| K881283 | MEADOX INTRA-AORTIC GRAFT | DSY | Substantially Equivalent | |
| K841596 | MEADOS INTRAORTIC GRAFT | DSY | Substantially Equivalent | |
| K854431 | MEADOX MEDICALS INC. GRAFT SIZER | DSY | Substantially Equivalent | |
| K840756 | BIOPATCH BOVINE PERICARDIAL PATCH | DQX | Substantially Equivalent | |
| K833616 | OLBERT CATHETER SYSTEM | LIT | Substantially Equivalent | |
| K822633 | MICROVEL DOUBLE VELOUR SUPPORTED 100 | DSY | Substantially Equivalent | |
| K820696 | MEADOX WOVEN DOUBLE VELOUR | DSY | Substantially Equivalent | |
| K812248 | COOLEY 2 VASCULAR PROSTHESIS STRAIGHT | DSY | Substantially Equivalent | |
| K811441 | MANUFACTURING PROCESS CHANGE | DSY | Substantially Equivalent | |
| K810845 | DOUBLE VELOUR GRAFTS | DSY | Substantially Equivalent | |
| K810376 | MEADOX SZILAGYI GRAFT | DSY | Substantially Equivalent | |
| K760516 | FELT, SURGICAL DACRON | DXZ | Substantially Equivalent | |
| K760443 | CARDIAC ELECTRODE | DTB | Substantially Equivalent | |
| K760092 | GRAFT, COOLEY WOVEN VASCULAR, STERILE | DSY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LITCatheter, Angioplasty, Peripheral, Transluminal
- LJECatheter, Nephrostomy
- EZNDilator, Catheter, Ureteral
- DPWFlowmeter, Blood, Cardiovascular
- MALGraft, Vascular, Synthetic/Biologic Composite
- KNWInstrument, Biopsy
- KDCInstrument, Surgical, Disposable
- DWSInstruments, Surgical, Cardiovascular
- LMLLigaments And Tendons, Synthetic
- FTLMesh, Surgical, Polymeric
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- DTBPermanent Pacemaker Electrode
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter
- 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
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Data as of , FDA export datePage updated Source: openFDA, public domain