Chrysalis Intelligence · Sponsors · Oridion Medical 1987 , Ltd.

Oridion Medical 1987 , Ltd.

Jerusalem, IL · 1 510(k) clearances · 10 recalls

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Total clearances
1
2020-04-27 → 2020-04-27
Last 12 months
0
Product codes
1
Most recent
2020-04-27
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Class II Anesthesiology 1 2020-04-27
Safety

Recalls (10)

Class I (serious)
0
Risk of injury / death
Total recalls
10
Currently ongoing
10
Most recent
2025-02-17
DateSeverityStatusRecall # ProductCodeReason
2025-02-17 Class II Ongoing Z-1385-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated… — Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficul…
2025-02-17 Class II Ongoing Z-1384-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated… — Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficul…
2025-02-17 Class II Ongoing Z-1383-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Ad… — Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficul…
2025-02-17 Class II Ongoing Z-1382-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intub… — Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficul…
2025-02-17 Class II Ongoing Z-1381-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediat… — Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficul…
2025-02-17 Class II Ongoing Z-1380-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - … — Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficul…
2025-02-17 Class II Ongoing Z-1379-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampli… — Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficul…
2025-02-17 Class II Ongoing Z-1378-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediat… — Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficul…
2025-02-17 Class II Ongoing Z-1377-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Se… — Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficul…
2025-02-17 Class II Ongoing Z-1376-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H… — Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficul…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2020-04-27 K200594 Capnostream 35 Portable Respiratory Monitor CCK Class II Anesthesiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence