Oridion Medical 1987 , Ltd. is one of 267 FDA 510(k) medical device manufacturers from Israel in the dataset, ranked by real submission volume.
Oridion Medical 1987 , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Capnostream 35 Portable Respiratory Monitor, 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, Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line
19
Total
19
Cleared
0
Denied
Oridion Medical 1987 , Ltd. has 19 FDA 510(k) cleared anesthesiology devices. Based in Jerusalem, IL.
Historical record: 19 cleared submissions from 2001 to 2020.
Browse the complete list of FDA 510(k) cleared anesthesiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Hogan Lovells US LLP as regulatory consultant.
FDA 510(k) Regulatory Record - Oridion Medical 1987 , Ltd.
19 devices
Cleared
Apr 27, 2020
Capnostream 35 Portable Respiratory Monitor
Anesthesiology
52d
Cleared
Mar 22, 2019
Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing,...
Anesthesiology
275d
Cleared
Feb 08, 2019
Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance...
Anesthesiology
249d
Cleared
Jul 17, 2015
Capnostream 35 Portable Respiratory Monitor
Anesthesiology
163d
Cleared
Aug 05, 2014
CAPNOSTREAM20P WITH HIFI C02 MONITORING
Anesthesiology
610d
Cleared
Nov 29, 2012
MICROSTREAM FILTERLINE ICU
Anesthesiology
150d
Cleared
Jul 19, 2012
CAPNOSTREAM20P WITH AI/ODI
Anesthesiology
337d
Cleared
Mar 04, 2010
SMART CAPNOLINE GUARDIAN
Anesthesiology
125d
Cleared
Nov 23, 2004
SMART BITEBLOC
Anesthesiology
55d
Cleared
Apr 03, 2003
MICROCAP PLUS/NPB-75
Anesthesiology
100d
Cleared
Nov 29, 2001
MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE
Anesthesiology
9d
Cleared
Nov 14, 2001
MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE
Anesthesiology
180d
Cleared
Aug 15, 2001
MAC-LINE CO2 NASAL CANNULA SAMPLE LINE
Anesthesiology
19d
Cleared
Aug 15, 2001
ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE
Anesthesiology
19d
Cleared
Aug 15, 2001
MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE
Anesthesiology
19d
Cleared
Jul 09, 2001
VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI
Microbiology
53d
Cleared
May 04, 2001
MICROSTREAM ORAL NASAL CANNULA FILTERLINE
Anesthesiology
28d
Cleared
Mar 14, 2001
O2/CO2 NASAL FILTERLINE
Anesthesiology
70d
Cleared
Jan 11, 2001
MICROSTREAM EXTERNAL BATTERY CHARGER
Anesthesiology
177d