Oridion Medical 1987 , Ltd.
Oridion Medical 1987 , Ltd. holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2020, with 47 FDA device recalls on record.
Top product codes for Oridion Medical 1987 , Ltd.
FDA recalls by Oridion Medical 1987 , Ltd.
10 most recent of 47- 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.
- 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;
- 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
- 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
- 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
- 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.
- 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
- 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
- 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
- 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;
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Oridion Medical 1987 , Ltd.
- K200594 — Capnostream 35 Portable Respiratory Monitor
- 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
- K181467 — Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line
- K150272 — Capnostream 35 Portable Respiratory Monitor
- K123690 — CAPNOSTREAM20P WITH HIFI C02 MONITORING
- K121927 — MICROSTREAM FILTERLINE ICU
- K112368 — CAPNOSTREAM20P WITH AI/ODI
- K093388 — SMART CAPNOLINE GUARDIAN
- K042665 — SMART BITEBLOC
- K024300 — MICROCAP PLUS/NPB-75
- K013845 — MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE
- K011536 — MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE
- K012391 — MAC-LINE CO2 NASAL CANNULA SAMPLE LINE
- K012394 — ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE
- K012395 — MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE
- K011668 — VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI
- K011050 — MICROSTREAM ORAL NASAL CANNULA FILTERLINE
- K010024 — O2/CO2 NASAL FILTERLINE
- K002163 — MICROSTREAM EXTERNAL BATTERY CHARGER
Data sourced from openFDA. This site is unofficial and independent of the FDA.