Company · US
Medi-Globe Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2026. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FCG | Biopsy Needle | 7 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 6 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 2 |
| FDI | Snare, Flexible | 2 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 |
| FCL | Forceps, Biopsy, Non-Electric | 1 |
| KGE | Forceps, Biopsy, Electric | 1 |
| LQC | Lithotriptor, Biliary Mechanical | 1 |
| LQR | Dislodger, Stone, Biliary | 1 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 1 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 16, 2026 | K251658 | Endoflux Biliary & Pancreatic Stent Sets Medi-Globe GmbH, DE | FGE |
| May 19, 2016 | K153264 | EasyPass Guidewire Medi-Globe Corporation | OCY |
| Sep 30, 2014 | K142258 | PolyCatch Retrieval Device Medi-Globe Corporation | FDI |
| May 15, 2014 | K133763 | SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM Medi-Globe Corporation | FCG |
| May 8, 2009 | K091257 | MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM Medi-Globe Corporation | FCG |
| Mar 20, 2009 | K083802 | SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 Medi-Globe Corporation | FCG |
| Jan 31, 2007 | K070129 | SONOTIP II ULTRASOUND NEEDLE SYSTEM Medi-Globe Corporation | FCG |
| Jul 3, 2006 | K061222 | INJECTRA INJECTION NEEDLE Medi-Globe Corp. | FBK |
| Jun 27, 2006 | K061684 | MEDI-GLOBE ROTA-CUT SPHINCTEROTOME Medi-Globe Corporation | KNS |
| Jun 16, 2005 | K051247 | SONOTIP II ULTRASOUND NEEDLE SYSTEM Medi-Globe Corp. | FCG |
| Nov 17, 2003 | K011261 | STONE EXTRACTOR BALLOON CATHETER Medi-Globe Corp. | FGE |
| Jan 21, 2003 | K010714 | EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830 Medi-Globe Corp., DE | FGE |
| Jan 18, 2002 | K010549 | BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) Medi-Globe Corp. | FGE |
| Mar 31, 1999 | K990220 | MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM Medi-Globe Corp. | FCG |
| Apr 4, 1996 | K953355 | GIP/MEID-GLOBE HOT BIOPSY FORCEPS Medi-Globe Corp. | KGE |
| Feb 29, 1996 | K955558 | GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES Medi-Globe Corp. | FBK |
| Sep 1, 1995 | K953827 | GIP/MEDI-GLOBE ERCP CATHETERS Medi-Globe Corp. | FGE |
| Jun 30, 1995 | K941973 | GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES Medi-Globe Corp. | FGE |
| May 26, 1995 | K943935 | GIP/MEDI-GLOBE POLYPECTOMY SNARES Medi-Globe Corp. | FDI |
| May 26, 1995 | K943629 | GIP/MEDI-GLOBE PAPILLOTOME Medi-Globe Corp. | KNS |
| Feb 13, 1995 | K935844 | GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA Medi-Globe Corp. | FCG |
| Dec 15, 1994 | K943476 | GIP/MEDI-GLOBE GOREIGN BODY GRASPERS Medi-Globe Corp. | OCZ |
| Nov 22, 1994 | K942544 | GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS Medi-Globe Corp. | LQC |
| Nov 22, 1994 | K942005 | GIP/MED-GLOBE STONE EXTRACTOR BASKETS Medi-Globe Corp. | LQR |
| Jul 12, 1994 | K941359 | GIP/MEDI-GLOBE BIOPSY FORCEPS Medi-Globe Corp. | FCL |
| Jul 31, 1990 | K900459 | APPLICARD (EKG) Medi-Globe Corp. | DRY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||