Oridion Medical 1987 Ltd.
Jerusalem, IL
ORIDION MEDICAL 1987 LTD. appears in FDA device records in Jerusalem, IL. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 76 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Oridion Medical 1987 Ltd. between 2001 and 2020. The busiest year on record is 2001, with 9. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 9 |
| 2003 | 1 |
| 2004 | 1 |
| 2010 | 1 |
| 2012 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200594 | Capnostream 35 Portable Respiratory Monitor | CCK | Substantially Equivalent | |
| K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line | CCK | Substantially Equivalent | |
| K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line | CCK | Substantially Equivalent | |
| K150272 | Capnostream 35 Portable Respiratory Monitor | CCK | Substantially Equivalent | |
| K123690 | CAPNOSTREAM20P WITH HIFI C02 MONITORING | CCK | Substantially Equivalent | |
| K121927 | MICROSTREAM FILTERLINE ICU | CCK | Substantially Equivalent | |
| K112368 | CAPNOSTREAM20P WITH AI/ODI | CCK | Substantially Equivalent | |
| K093388 | SMART CAPNOLINE GUARDIAN | CCK | Substantially Equivalent | |
| K042665 | SMART BITEBLOC | CCK | Substantially Equivalent | |
| K024300 | MICROCAP PLUS/NPB-75 | DQA | Substantially Equivalent | |
| K013845 | MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE | CCK | Substantially Equivalent | |
| K011536 | MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE | CCK | Substantially Equivalent | |
| K012395 | MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE | CCK | Substantially Equivalent | |
| K012394 | ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE | CCK | Substantially Equivalent | |
| K012391 | MAC-LINE CO2 NASAL CANNULA SAMPLE LINE | CCK | Substantially Equivalent | |
| K011668 | VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI | MSQ | Substantially Equivalent | |
| K011050 | MICROSTREAM ORAL NASAL CANNULA FILTERLINE | CCK | Substantially Equivalent | |
| K010024 | O2/CO2 NASAL FILTERLINE | CCK | Substantially Equivalent | |
| K002163 | MICROSTREAM EXTERNAL BATTERY CHARGER | CCK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8044004 | 3001227743 | ORIDION MEDICAL 1987 LTD. | 7 HAMARPE ST. P.O. BOX 45025, JERUSALEM 9777407 IL | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- ORTBurst Suppression Detection Software For Electroencephalograph
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BZAConnector, Airway (Extension)
- BYHDrain, Tee (Water Trap)
- GXYElectrode, Cutaneous
- OLWIndex-Generating Electroencephalograph Software
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- DQAOximeter
- OMCReduced- Montage Standard Electroencephalograph
- BTKStrap, Head, Gas Mask
- MSQTest, Urea (Breath Or Blood)
- MNRVentilatory Effort Recorder
Recall records
Showing 25 of 76| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1385-2025 | Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVIIH; Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft High Humidity, MVIIHH; Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 4m/13ft Extended Duration, MVIIHL; Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, ZMVIIH | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation. | Class II | Open, Classified | |
| Z-1384-2025 | Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, MVAI; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, MVAI100U; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVAIH; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVAIH100U; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft High Humidity, MVAIHH; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 4m/13ft Extended Duration, MVAIHL; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 4m/13ft Short-term use: Procedural/Emergency, MVAIL; Microstream Advance Air Military Sample Kit CO2 Oral-Nasal Filter Line with O2 Tubing (MVAO) and Adult-Pediatric Intubated Filter Line, High Humidity (MVAIHH) 2m/6.5ft, MVAMSK; Microstream Advance Adult Sample Kit CO2 Intubated Filter Line (MVAI) and CO2 Oral-Nasal Filter Line with O2 Connector (MVA) 2m/6.5ft, MVASK; Microstream Advance Adult-Pediatric IntubatedCO2 Filter Line 2m/6.5ft Extended Duration, ZMVAIH; Microstream Advance Adult-Pediatric IntubatedCO2 Filter Line 2m/6.5ft High Humidity, ZMVAIHH; Microstream Advance Adult-Pediatric IntubatedCO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, ZMVAI; | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation. | Class II | Open, Classified | |
| Z-1383-2025 | Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation. | Class II | Open, Classified | |
| Z-1382-2025 | Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVIIH | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation. | Class II | Open, Classified | |
| Z-1381-2025 | Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, QMVAI; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVAIH | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation. | Class II | Open, Classified | |
| Z-1380-2025 | Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 012495; | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation. | Class II | Open, Classified | |
| Z-1379-2025 | Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Sampling Line X25, 010991 | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation. | Class II | Open, Classified | |
| Z-1378-2025 | Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), 006324COV; CapnoLine Adult-Pediatric Intubated Filter Line with Microstream Technology Length 7 (2.0 m), XS04620COV; CapnoLine Adult-Pediatric Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), XS04624COV | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation. | Class II | Open, Classified | |
| Z-1377-2025 | Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 007737; MICROSTREAM FilterLine Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter, 007768; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 010579; MICROSTREAM FilterLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 010580; MICROSTREAM VitaLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for High Ambient Humidity X25, 010787; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 015016; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 015021; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, XS04620; MICROSTREAM FilterLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, XS04624. | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation. | Class II | Open, Classified | |
| Z-1376-2025 | Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM FilterLine H Set Long Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 007738; MICROSTREAM VitaLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 010807. | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation. | Class II | Open, Classified | |
| Z-0056-2019 | CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | Class II | Terminated | |
| Z-0055-2019 | CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | Class II | Terminated | |
| Z-0054-2019 | Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | Class II | Terminated | |
| Z-0053-2019 | Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | Class II | Terminated | |
| Z-0052-2019 | Capnostream20 (INTL) M REFURBISHED, CS78654 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | Class II | Terminated | |
| Z-0051-2019 | Capnostream20 (INTL) N REFURBISHED, CS78652 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | Class II | Terminated | |
| Z-0050-2019 | Capnostream20 N CYVITAL, CS08799 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | Class II | Terminated | |
| Z-0049-2019 | Capnostream20 N W/PRINTER CYVITAL, CS08798 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | Class II | Terminated | |
| Z-0048-2019 | Capnostream20 M W/PRINTER CYVITAL, CS08796 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | Class II | Terminated | |
| Z-0047-2019 | Capnostream20 (INTL) M W/PRINTER, CS08660 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | Class II | Terminated | |
| Z-0046-2019 | Capnostream20 M NICU (CPM), CS08654RN | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | Class II | Terminated | |
| Z-0045-2019 | Capnostream20 M ADULT ICU (CPM), CS08654RA | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | Class II | Terminated | |
| Z-0044-2019 | Capnostream20 (INTL) M, CS08654 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | Class II | Terminated | |
| Z-0043-2019 | CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | Class II | Terminated | |
| Z-0042-2019 | CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain