Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Meadox Medicals, Div. Boston Scientific Corp. · Predicate Candidate Screening
53 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
351 days90th percentile
53clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953647 | MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING | Meadox Medicals, Div. Boston Scientific Corp. | 1997-05-16 | 651 | 0 |
| K960766 | MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1997-03-19 | 387 | 0 |
| K962433 | MEADOX EXXCEL EPTFE VASCULAR GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1997-03-17 | 266 | 0 |
| K961847 | HEMASHIELD VANTAGE (VASCULAR GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1997-01-22 | 254 | 1 |
| K962342 | HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH | Meadox Medicals, Div. Boston Scientific Corp. | 1996-09-10 | 84 | 2 |
| K955460 | MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPAN | Meadox Medicals, Div. Boston Scientific Corp. | 1996-05-30 | 183 | 0 |
| K952884 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-21 | 243 | 0 |
| K955349 | HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-14 | 85 | 2 |
| K953298 | MS CLASSIQUE BALLOON DIATATION CATHETER | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-08 | 209 | 0 |
| K954848 | HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-01 | 101 | 1 |
| K953608 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER | Meadox Medicals, Div. Boston Scientific Corp. | 1995-12-20 | 140 | 0 |
| K953691 | MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING | Meadox Medicals, Div. Boston Scientific Corp. | 1995-10-16 | 69 | 0 |
| K953332 | MS CLASSIQUE BALLOON DILATATION CAHTETER | Meadox Medicals, Div. Boston Scientific Corp. | 1995-10-07 | 82 | 0 |
| K953597 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER | Meadox Medicals, Div. Boston Scientific Corp. | 1995-10-07 | 67 | 0 |
| K952887 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER | Meadox Medicals, Div. Boston Scientific Corp. | 1995-08-18 | 56 | 0 |
| K943358 | NAVIGUIDE HYDROPHILIC GUIDE WIRE | Meadox Medicals, Div. Boston Scientific Corp. | 1995-06-02 | 325 | 0 |
| K944989 | NOPROFILE OLBERT CATHETER SYSTEM | Meadox Medicals, Div. Boston Scientific Corp. | 1995-04-26 | 196 | 0 |
| K945576 | MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R) | Meadox Medicals, Div. Boston Scientific Corp. | 1995-01-24 | 71 | 0 |
| K945377 | TRELEX NATURAL(R) MESH | Meadox Medicals, Div. Boston Scientific Corp. | 1994-12-08 | 45 | 0 |
| K942635 | MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM | Meadox Medicals, Div. Boston Scientific Corp. | 1994-11-01 | 151 | 0 |
| K942293 | MS CLASSIQUE BALLOON CATHETER | Meadox Medicals, Div. Boston Scientific Corp. | 1994-10-18 | 160 | 0 |
| K943298 | MS CLASSIQUE BALLOON CATHETER | Meadox Medicals, Div. Boston Scientific Corp. | 1994-09-08 | 62 | 0 |
| K936226 | SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET | Meadox Medicals, Div. Boston Scientific Corp. | 1994-03-07 | 68 | 0 |
| K934411 | MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE | Meadox Medicals, Div. Boston Scientific Corp. | 1994-01-07 | 119 | 0 |
| K933975 | MEADOX SURGIMED DISPOSABLE PRESSURE GUAGE FOR USE WITH THE O | Meadox Medicals, Div. Boston Scientific Corp. | 1993-10-06 | 54 | 0 |
| K923947 | MEADOX SURGIMED BALLOON CATHETER | Meadox Medicals, Div. Boston Scientific Corp. | 1993-09-30 | 421 | 0 |
| K930227 | MS DISPOSABLE RIGID DOPPLER PROBE | Meadox Medicals, Div. Boston Scientific Corp. | 1993-09-16 | 240 | 0 |
| K931386 | HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC | Meadox Medicals, Div. Boston Scientific Corp. | 1993-05-27 | 70 | 0 |
| K921706 | MEADOX(R) SURGIMED OLBERT CATHETER SYSTEM(R) | Meadox Medicals, Div. Boston Scientific Corp. | 1993-05-20 | 405 | 0 |
| K930622 | AMPLATZ GUIDEWIRES | Meadox Medicals, Div. Boston Scientific Corp. | 1993-04-29 | 80 | 0 |
| K922674 | NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE | Meadox Medicals, Div. Boston Scientific Corp. | 1992-12-21 | 200 | 0 |
| K924749 | TRELEX MESH | Meadox Medicals, Div. Boston Scientific Corp. | 1992-11-23 | 62 | 0 |
| K922879 | MEADOX SURGIMED BIOPSY GUN III | Meadox Medicals, Div. Boston Scientific Corp. | 1992-09-01 | 78 | 0 |
| K912798 | AMPLANTZ AND BENTSON GUIDEWIRES | Meadox Medicals, Div. Boston Scientific Corp. | 1991-09-23 | 90 | 0 |
| K904410 | MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM) | Meadox Medicals, Div. Boston Scientific Corp. | 1991-03-25 | 180 | 0 |
| K905496 | WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS | Meadox Medicals, Div. Boston Scientific Corp. | 1991-03-11 | 94 | 0 |
| K881283 | MEADOX INTRA-AORTIC GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1988-05-26 | 62 | 0 |
| K841596 | MEADOS INTRAORTIC GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1986-05-08 | 750 | 0 |
| K854431 | MEADOX MEDICALS INC. GRAFT SIZER | Meadox Medicals, Div. Boston Scientific Corp. | 1986-05-07 | 183 | 0 |
| K840756 | BIOPATCH BOVINE PERICARDIAL PATCH | Meadox Medicals, Div. Boston Scientific Corp. | 1985-02-08 | 351 | 0 |
| K833616 | OLBERT CATHETER SYSTEM | Meadox Medicals, Div. Boston Scientific Corp. | 1983-12-26 | 74 | 0 |
| K822633 | MICROVEL DOUBLE VELOUR SUPPORTED 100 | Meadox Medicals, Div. Boston Scientific Corp. | 1983-07-12 | 315 | 0 |
| K820696 | MEADOX WOVEN DOUBLE VELOUR | Meadox Medicals, Div. Boston Scientific Corp. | 1982-07-09 | 119 | 0 |
| K812248 | COOLEY 2 VASCULAR PROSTHESIS STRAIGHT | Meadox Medicals, Div. Boston Scientific Corp. | 1981-11-24 | 105 | 0 |
| K811441 | MANUFACTURING PROCESS CHANGE | Meadox Medicals, Div. Boston Scientific Corp. | 1981-09-16 | 117 | 0 |
| K810845 | DOUBLE VELOUR GRAFTS | Meadox Medicals, Div. Boston Scientific Corp. | 1981-05-08 | 42 | 0 |
| K810376 | MEADOX SZILAGYI GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1981-03-05 | 21 | 0 |
| K760516 | FELT, SURGICAL DACRON | Meadox Medicals, Div. Boston Scientific Corp. | 1977-01-05 | 133 | 0 |
| K760443 | CARDIAC ELECTRODE | Meadox Medicals, Div. Boston Scientific Corp. | 1976-08-26 | 10 | 0 |
| K760087 | TAPE, VASCULAR, 1/4 DACRON | Meadox Medicals, Div. Boston Scientific Corp. | 1976-07-20 | 29 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda