Company ยท US
Meadox Medicals, Div. Boston Scientific Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1997. Name variants (Inc, Corp, punctuation) are merged.
53510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 15 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 14 |
| DQX | Wire, Guide, Catheter | 5 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 5 |
| EZN | Dilator, Catheter, Ureteral | 3 |
| FTL | Mesh, Surgical, Polymeric | 2 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 |
| DTB | Permanent Pacemaker Electrode | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 |
| DYF | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 |
| KDC | Instrument, Surgical, Disposable | 1 |
| KNW | Instrument, Biopsy | 1 |
| LJE | Catheter, Nephrostomy | 1 |
| MAL | Graft, Vascular, Synthetic/Biologic Composite | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 16, 1997 | K953647 | MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Mar 19, 1997 | K960766 | MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT Meadox Medicals, Div. Boston Scientific Corp. | DYF |
| Mar 17, 1997 | K962433 | MEADOX EXXCEL EPTFE VASCULAR GRAFT Meadox Medicals, Div. Boston Scientific Corp. | DSY |
| Jan 22, 1997 | K961847 | HEMASHIELD VANTAGE (VASCULAR GRAFT Meadox Medicals, Div. Boston Scientific Corp. | DSY |
| Sep 10, 1996 | K962342 | HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH Meadox Medicals, Div. Boston Scientific Corp. | DXZ |
| May 30, 1996 | K955460 | MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT Meadox Medicals, Div. Boston Scientific Corp. | DSY |
| Feb 21, 1996 | K952884 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Feb 14, 1996 | K955349 | HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC Meadox Medicals, Div. Boston Scientific Corp. | DXZ |
| Feb 8, 1996 | K953298 | MS CLASSIQUE BALLOON DIATATION CATHETER Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Feb 1, 1996 | K954848 | HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT Meadox Medicals, Div. Boston Scientific Corp. | MAL |
| Dec 20, 1995 | K953608 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Oct 16, 1995 | K953691 | MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING Meadox Medicals, Div. Boston Scientific Corp. | EZN |
| Oct 7, 1995 | K953597 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER Meadox Medicals, Div. Boston Scientific Corp. | EZN |
| Oct 7, 1995 | K953332 | MS CLASSIQUE BALLOON DILATATION CAHTETER Meadox Medicals, Div. Boston Scientific Corp. | FGE |
| Aug 18, 1995 | K952887 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER Meadox Medicals, Div. Boston Scientific Corp. | LJE |
| Jun 2, 1995 | K943358 | NAVIGUIDE HYDROPHILIC GUIDE WIRE Meadox Medicals, Div. Boston Scientific Corp. | DQX |
| Apr 26, 1995 | K944989 | NOPROFILE OLBERT CATHETER SYSTEM Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Jan 24, 1995 | K945576 | MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R) Meadox Medicals, Div. Boston Scientific Corp. | EZN |
| Dec 8, 1994 | K945377 | TRELEX NATURAL(R) MESH Meadox Medicals, Div. Boston Scientific Corp. | FTL |
| Nov 1, 1994 | K942635 | MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Oct 18, 1994 | K942293 | MS CLASSIQUE BALLOON CATHETER Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Sep 8, 1994 | K943298 | MS CLASSIQUE BALLOON CATHETER Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Mar 7, 1994 | K936226 | SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET Meadox Medicals, Div. Boston Scientific Corp. | KDC |
| Jan 7, 1994 | K934411 | MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Oct 6, 1993 | K933975 | MEADOX SURGIMED DISPOSABLE PRESSURE GUAGE FOR USE WITH THE OLBERT CATHETER SYSTEM Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Sep 30, 1993 | K923947 | MEADOX SURGIMED BALLOON CATHETER Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Sep 16, 1993 | K930227 | MS DISPOSABLE RIGID DOPPLER PROBE Meadox Medicals, Div. Boston Scientific Corp. | DPW |
| May 27, 1993 | K931386 | HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC Meadox Medicals, Div. Boston Scientific Corp. | DXZ |
| May 20, 1993 | K921706 | MEADOX(R) SURGIMED OLBERT CATHETER SYSTEM(R) Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Apr 29, 1993 | K930622 | AMPLATZ GUIDEWIRES Meadox Medicals, Div. Boston Scientific Corp. | DQX |
| Dec 21, 1992 | K922674 | NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE Meadox Medicals, Div. Boston Scientific Corp. | DQX |
| Nov 23, 1992 | K924749 | TRELEX MESH Meadox Medicals, Div. Boston Scientific Corp. | FTL |
| Sep 1, 1992 | K922879 | MEADOX SURGIMED BIOPSY GUN III Meadox Medicals, Div. Boston Scientific Corp. | KNW |
| Sep 23, 1991 | K912798 | AMPLANTZ AND BENTSON GUIDEWIRES Meadox Medicals, Div. Boston Scientific Corp. | DQX |
| Mar 25, 1991 | K904410 | MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM) Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Mar 11, 1991 | K905496 | WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS Meadox Medicals, Div. Boston Scientific Corp. | DXZ |
| May 26, 1988 | K881283 | MEADOX INTRA-AORTIC GRAFT Meadox Medicals, Div. Boston Scientific Corp. | DSY |
| May 8, 1986 | K841596 | MEADOS INTRAORTIC GRAFT Meadox Medicals, Div. Boston Scientific Corp. | DSY |
| May 7, 1986 | K854431 | MEADOX MEDICALS INC. GRAFT SIZER Meadox Medicals, Div. Boston Scientific Corp. | DSY |
| Feb 8, 1985 | K840756 | BIOPATCH BOVINE PERICARDIAL PATCH Meadox Medicals, Div. Boston Scientific Corp. | DQX |
| Dec 26, 1983 | K833616 | OLBERT CATHETER SYSTEM Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Jul 12, 1983 | K822633 | MICROVEL DOUBLE VELOUR SUPPORTED 100 Meadox Medicals, Div. Boston Scientific Corp. | DSY |
| Jul 9, 1982 | K820696 | MEADOX WOVEN DOUBLE VELOUR Meadox Medicals, Div. Boston Scientific Corp. | DSY |
| Nov 24, 1981 | K812248 | COOLEY 2 VASCULAR PROSTHESIS STRAIGHT Meadox Medicals, Div. Boston Scientific Corp. | DSY |
| Sep 16, 1981 | K811441 | MANUFACTURING PROCESS CHANGE Meadox Medicals, Div. Boston Scientific Corp. | DSY |
| May 8, 1981 | K810845 | DOUBLE VELOUR GRAFTS Meadox Medicals, Div. Boston Scientific Corp. | DSY |
| Mar 5, 1981 | K810376 | MEADOX SZILAGYI GRAFT Meadox Medicals, Div. Boston Scientific Corp. | DSY |
| Jan 5, 1977 | K760516 | FELT, SURGICAL DACRON Meadox Medicals, Div. Boston Scientific Corp. | DXZ |
| Aug 26, 1976 | K760443 | CARDIAC ELECTRODE Meadox Medicals, Div. Boston Scientific Corp. | DTB |
| Jul 20, 1976 | K760092 | GRAFT, COOLEY WOVEN VASCULAR, STERILE Meadox Medicals, Div. Boston Scientific Corp. | DSY |
Newest 50 of 53.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||