Oridion Medical 1987 Ltd.
FDA Regulatory Profile
Oridion Medical 1987 Ltd. appears in FDA public data with 47 recalls, 19 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1381-2025, Class II) was initiated on February 17, 2025. Its most recent 510(k) clearance was granted on April 27, 2020.
Summary
- Total Recalls
- 47
- 510(k) Clearances
- 19
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1381-2025 | Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstre | February 17, 2025 |
| Z-1377-2025 | Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLin | February 17, 2025 |
| Z-1378-2025 | Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Li | February 17, 2025 |
| Z-1376-2025 | Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLin | February 17, 2025 |
| Z-1380-2025 | Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentL | February 17, 2025 |
| Z-1385-2025 | Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstre | February 17, 2025 |
| Z-1382-2025 | Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstre | February 17, 2025 |
| Z-1379-2025 | Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Ad | February 17, 2025 |
| Z-1384-2025 | Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstre | February 17, 2025 |
| Z-1383-2025 | Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstre | February 17, 2025 |
| Z-0045-2019 | Class II | Capnostream20 M ADULT ICU (CPM), CS08654RA | July 31, 2018 |
| Z-0048-2019 | Class II | Capnostream20 M W/PRINTER CYVITAL, CS08796 | July 31, 2018 |
| Z-0056-2019 | Class II | CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03 | July 31, 2018 |
| Z-0040-2019 | Class II | CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658 | July 31, 2018 |
| Z-0049-2019 | Class II | Capnostream20 N W/PRINTER CYVITAL, CS08798 | July 31, 2018 |
| Z-0055-2019 | Class II | CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV | July 31, 2018 |
| Z-0027-2019 | Class II | CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03 | July 31, 2018 |
| Z-0028-2019 | Class II | Capnostream20 (US) M, Part Number CS08653 | July 31, 2018 |
| Z-0053-2019 | Class II | Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658 | July 31, 2018 |
| Z-0023-2019 | Class II | CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03 | July 31, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K200594 | Capnostream 35 Portable Respiratory Monitor | April 27, 2020 |
| K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric | March 22, 2019 |
| K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intuba | February 8, 2019 |
| K150272 | Capnostream 35 Portable Respiratory Monitor | July 17, 2015 |
| K123690 | CAPNOSTREAM20P WITH HIFI C02 MONITORING | August 5, 2014 |
| K121927 | MICROSTREAM FILTERLINE ICU | November 29, 2012 |
| K112368 | CAPNOSTREAM20P WITH AI/ODI | July 19, 2012 |
| K093388 | SMART CAPNOLINE GUARDIAN | March 4, 2010 |
| K042665 | SMART BITEBLOC | November 23, 2004 |
| K024300 | MICROCAP PLUS/NPB-75 | April 3, 2003 |
| K013845 | MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE | November 29, 2001 |
| K011536 | MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE | November 14, 2001 |
| K012394 | ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE | August 15, 2001 |
| K012391 | MAC-LINE CO2 NASAL CANNULA SAMPLE LINE | August 15, 2001 |
| K012395 | MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE | August 15, 2001 |
| K011668 | VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI | July 9, 2001 |
| K011050 | MICROSTREAM ORAL NASAL CANNULA FILTERLINE | May 4, 2001 |
| K010024 | O2/CO2 NASAL FILTERLINE | March 14, 2001 |
| K002163 | MICROSTREAM EXTERNAL BATTERY CHARGER | January 11, 2001 |