Company ยท IL
Oridion Medical 1987 Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2020. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
76recalls (0 in 12 months)
50recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 27, 2020 | K200594 | Capnostream 35 Portable Respiratory Monitor Oridion Medical 1987 , Ltd., IL | CCK |
| Mar 22, 2019 | K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Li Oridion Medical 1987 , Ltd., IL | CCK |
| Feb 8, 2019 | K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line Oridion Medical 1987 , Ltd., IL | CCK |
| Jul 17, 2015 | K150272 | Capnostream 35 Portable Respiratory Monitor Oridion Medical 1987 , Ltd., IL | CCK |
| Aug 5, 2014 | K123690 | CAPNOSTREAM20P WITH HIFI C02 MONITORING Oridion Medical 1987 , Ltd., IL | CCK |
| Nov 29, 2012 | K121927 | MICROSTREAM FILTERLINE ICU Oridion Medical 1987 , Ltd., IL | CCK |
| Jul 19, 2012 | K112368 | CAPNOSTREAM20P WITH AI/ODI Oridion Medical 1987 , Ltd., IL | CCK |
| Mar 4, 2010 | K093388 | SMART CAPNOLINE GUARDIAN Oridion Medical 1987 , Ltd., IL | CCK |
| Nov 23, 2004 | K042665 | SMART BITEBLOC Oridion Medical 1987 , Ltd., IL | CCK |
| Apr 3, 2003 | K024300 | MICROCAP PLUS/NPB-75 Oridion Medical 1987 , Ltd., IL | DQA |
| Nov 29, 2001 | K013845 | MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE Oridion Medical 1987 , Ltd., IL | CCK |
| Nov 14, 2001 | K011536 | MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE Oridion Medical 1987 , Ltd., IL | CCK |
| Aug 15, 2001 | K012395 | MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE Oridion Medical 1987 , Ltd., IL | CCK |
| Aug 15, 2001 | K012394 | ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE Oridion Medical 1987 , Ltd., IL | CCK |
| Aug 15, 2001 | K012391 | MAC-LINE CO2 NASAL CANNULA SAMPLE LINE Oridion Medical 1987 , Ltd., IL | CCK |
| Jul 9, 2001 | K011668 | VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI Oridion Medical 1987 , Ltd., IL | MSQ |
| May 4, 2001 | K011050 | MICROSTREAM ORAL NASAL CANNULA FILTERLINE Oridion Medical 1987 , Ltd., IL | CCK |
| Mar 14, 2001 | K010024 | O2/CO2 NASAL FILTERLINE Oridion Medical 1987 , Ltd., IL | CCK |
| Jan 11, 2001 | K002163 | MICROSTREAM EXTERNAL BATTERY CHARGER Oridion Medical 1987 , Ltd., IL | CCK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2025 | Oridion Medical 1987 Ltd. Microstream Instructions for Use and Part Number used with - Product Description, REF:
Microstream Advance Intubated Infant, PT00156250 -
Microstream Advance Neonatal-Infant Intubated CO2 Filter L Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. Microstream Instructions for Use and Part Number used with - Product Description, REF:
Microstream Advance Intubated Adult-Pediatric, PT00156254 -
Microstream Advance Adult-Pediatric Intubated CO2 Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. Microstream Instructions for Use and Part Number used with - Product Description, REF:
Microstream Luer Intubated Adult Pediatric, PT00156355 -
Microstream Luer Adult-Pediatric Intubated CO2 Sampl Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. 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 Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. Microstream Instructions for Use and Part Number used with - Product Description, REF:
Microstream Adv. Adult-Pediatric Intubated, PT00134333 -
Microstream Advance Adult-Pediatric Intubated CO2 Fi Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. 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; Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. 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;
Omnis Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. 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 Lin Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. 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 Open, Classified |
CCK | K181467 |
| Mar 17, 2025 | Oridion Medical 1987 Ltd. 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 S Open, Classified |
CCK | K181467 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (INTL) M REFURBISHED, CS78654 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (INTL) N REFURBISHED, CS78652 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 N CYVITAL, CS08799 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 N W/PRINTER CYVITAL, CS08798 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 M W/PRINTER CYVITAL, CS08796 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (INTL) M W/PRINTER, CS08660 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 M NICU (CPM), CS08654RN Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 M ADULT ICU (CPM), CS08654RA Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (INTL) M, CS08654 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20 (INTL) N, Part Number CS08652 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659 Terminated |
DQA | K082268 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657 Terminated |
DQA | K082268 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US)M REFURBISHED, Part Number CS78653 Terminated |
DQA | K082268 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US) N REFURBISHED, Part Number CS78651 Terminated |
DQA | None listed |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751 Terminated |
DQA | K082268 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US) M TO MASIMO, Part Number CS08750 Terminated |
DQA | K082268 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US) M W/PRINTER, Part Number CS08659 Terminated |
DQA | K082268 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US) M, Part Number CS08653 Terminated |
DQA | K082268 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03 Terminated |
CCK | K112368 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01 Terminated |
CCK | K112368 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02 Terminated |
CCK | K112368 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657 Terminated |
CCK | K082268 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03 Terminated |
DQA | K112368 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02 Terminated |
DQA | K112368 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N, Part Number CS08651-01 Terminated |
CCK | K112368 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20 (US) N, Part Number CS08651 Terminated |
DQA | K082268 |
| Mar 30, 2012 | Oridion Medical 1987 Ltd. Oridion Surestream CO2 Sampling Lines-
Sure VentLine H Set Adult/Pediatric
Part Number: 010987-03
Product Usage:
The intended use of SureStream sampling lines is to convey a sample of a patients exp Terminated |
CCK | K980327 |
| Mar 30, 2012 | Oridion Medical 1987 Ltd. Oridion Surestream CO2 Sampling Lines-
Sure VentLine Set Adult/Pediatric
Part Number: 010986-03
Product Usage:
The intended use of SureStream sampling lines is to convey a sample of a patients expire Terminated |
CCK | K980324 |
| Mar 30, 2012 | Oridion Medical 1987 Ltd. Oridion Surestream CO2 Sampling Lines-
SureLine O2
Part Number: 010979-03
Product Usage:
The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnogr Terminated |
CCK | K012395 |
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