Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medi-Globe Corp. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
211 daysmedian FDA review time
683 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061222 | INJECTRA INJECTION NEEDLE | Medi-Globe Corp. | 2006-07-03 | 62 | 0 |
| K051247 | SONOTIP II ULTRASOUND NEEDLE SYSTEM | Medi-Globe Corp. | 2005-06-16 | 31 | 0 |
| K011261 | STONE EXTRACTOR BALLOON CATHETER | Medi-Globe Corp. | 2003-11-17 | 936 | 0 |
| K010714 | EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420 | Medi-Globe Corp. | 2003-01-21 | 683 | 0 |
| K010549 | BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) | Medi-Globe Corp. | 2002-01-18 | 326 | 0 |
| K990220 | MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM | Medi-Globe Corp. | 1999-03-31 | 68 | 0 |
| K953355 | GIP/MEID-GLOBE HOT BIOPSY FORCEPS | Medi-Globe Corp. | 1996-04-04 | 262 | 0 |
| K955558 | GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES | Medi-Globe Corp. | 1996-02-29 | 85 | 0 |
| K953827 | GIP/MEDI-GLOBE ERCP CATHETERS | Medi-Globe Corp. | 1995-09-01 | 17 | 0 |
| K941973 | GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES | Medi-Globe Corp. | 1995-06-30 | 434 | 0 |
| K943935 | GIP/MEDI-GLOBE POLYPECTOMY SNARES | Medi-Globe Corp. | 1995-05-26 | 287 | 0 |
| K943629 | GIP/MEDI-GLOBE PAPILLOTOME | Medi-Globe Corp. | 1995-05-26 | 304 | 0 |
| K935844 | GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA | Medi-Globe Corp. | 1995-02-13 | 432 | 0 |
| K943476 | GIP/MEDI-GLOBE GOREIGN BODY GRASPERS | Medi-Globe Corp. | 1994-12-15 | 149 | 0 |
| K942544 | GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS | Medi-Globe Corp. | 1994-11-22 | 175 | 0 |
| K942005 | GIP/MED-GLOBE STONE EXTRACTOR BASKETS | Medi-Globe Corp. | 1994-11-22 | 211 | 0 |
| K941359 | GIP/MEDI-GLOBE BIOPSY FORCEPS | Medi-Globe Corp. | 1994-07-12 | 113 | 0 |
| K900459 | APPLICARD (EKG) | Medi-Globe Corp. | 1990-07-31 | 182 | 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