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Oridion Medical 1987 Ltd.

FDA Regulatory Profile

Summary

Total Recalls
47
510(k) Clearances
19
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1381-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF: MicrostreFebruary 17, 2025
Z-1377-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF: FilterLinFebruary 17, 2025
Z-1378-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF: Filter LiFebruary 17, 2025
Z-1376-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF: FilterLinFebruary 17, 2025
Z-1380-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLFebruary 17, 2025
Z-1385-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF: MicrostreFebruary 17, 2025
Z-1382-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF: MicrostreFebruary 17, 2025
Z-1379-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF: Airway AdFebruary 17, 2025
Z-1384-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF: MicrostreFebruary 17, 2025
Z-1383-2025Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF: MicrostreFebruary 17, 2025
Z-0055-2019Class IICAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COVJuly 31, 2018
Z-0027-2019Class IICAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03July 31, 2018
Z-0049-2019Class IICapnostream20 N W/PRINTER CYVITAL, CS08798July 31, 2018
Z-0026-2019Class IICAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01July 31, 2018
Z-0053-2019Class IICapnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658July 31, 2018
Z-0023-2019Class IICAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03July 31, 2018
Z-0052-2019Class IICapnostream20 (INTL) M REFURBISHED, CS78654July 31, 2018
Z-0030-2019Class IICapnostream20 (US) M TO MASIMO, Part Number CS08750July 31, 2018
Z-0048-2019Class IICapnostream20 M W/PRINTER CYVITAL, CS08796July 31, 2018
Z-0044-2019Class IICapnostream20 (INTL) M, CS08654July 31, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K200594Capnostream 35 Portable Respiratory MonitorApril 27, 2020
K181624Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric March 22, 2019
K181467Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric IntubaFebruary 8, 2019
K150272Capnostream 35 Portable Respiratory MonitorJuly 17, 2015
K123690CAPNOSTREAM20P WITH HIFI C02 MONITORINGAugust 5, 2014
K121927MICROSTREAM FILTERLINE ICUNovember 29, 2012
K112368CAPNOSTREAM20P WITH AI/ODIJuly 19, 2012
K093388SMART CAPNOLINE GUARDIANMarch 4, 2010
K042665SMART BITEBLOCNovember 23, 2004
K024300MICROCAP PLUS/NPB-75April 3, 2003
K013845MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINENovember 29, 2001
K011536MICROSTREAM O2/CO2 ORAL NASAL FILTERLINENovember 14, 2001
K012394ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINEAugust 15, 2001
K012395MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINEAugust 15, 2001
K012391MAC-LINE CO2 NASAL CANNULA SAMPLE LINEAugust 15, 2001
K011668VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORIJuly 9, 2001
K011050MICROSTREAM ORAL NASAL CANNULA FILTERLINEMay 4, 2001
K010024O2/CO2 NASAL FILTERLINEMarch 14, 2001
K002163MICROSTREAM EXTERNAL BATTERY CHARGERJanuary 11, 2001