Great Batch Medical
10 FDA 510(k) clearances · Manufacturer
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RadialSeal Introducer Kit (K181855) | Great Batch Medical | 2018-07-26 |
| MOBICATH BI-DIRECTIONAL GUIDING SHEATH (K130559) | Great Batch Medical | 2013-05-24 |
| MOBICATH TRANSSEPTAL NEEDLE (K122832) | Great Batch Medical | 2012-12-19 |
| Z FLEX-270TM STEERABLE SHEATH (K112541) | Great Batch Medical | 2012-02-07 |
| RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT (K110051) | Great Batch Medical | 2012-02-02 |
| MOBICATH TRANSSEPTAL NEEDLE (K111644) | Great Batch Medical | 2011-10-03 |
| MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX (K101784) | Great Batch Medical | 2010-11-26 |
| PTFE PORTABLE INTRODUCER (K102540) | Great Batch Medical | 2010-11-16 |
| OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER (K093232) | Great Batch Medical | 2010-03-15 |
| PTFE PEELABLE INTRODUCER (K093023) | Great Batch Medical | 2009-10-29 |
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Every clearance here is in the API, with alerts when new ones post.