Medical Device Manufacturer · SE , Uppsala

Radi Medical Systems AB - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 1990

Recent clearances: QUANTIEN MEASUREMENT SYSTEM, RADIANALYZER XPRESS, PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER

24

Total

24

Cleared

0

Denied

FDA 510(k) Regulatory Record - Radi Medical Systems AB Cardiovascular ✕

21 devices

1-12 of 21

Cleared Mar 28, 2013

QUANTIEN MEASUREMENT SYSTEM

Cardiovascular · 92d

Cleared Oct 09, 2009

RADIANALYZER XPRESS

Cardiovascular · 87d

Cleared Jul 01, 2008

PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER

Cardiovascular · 102d

Cleared Feb 26, 2008

MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM

Cardiovascular · 29d

Cleared Dec 04, 2006

PRESSUREWIRE CERTUS, MODELS 12006 AND 12306

Cardiovascular · 80d

Cleared Jan 19, 2005

MODIFICATION TO: RADIANALYZER, MODEL 12711

Cardiovascular · 114d

Cleared Jun 06, 2003

PRESSURE WIRE SENSOR, MODELS 12004/12304

Cardiovascular · 9d

Cleared Dec 24, 2002

FEMOSTOP FEMORAL COMPRESSION SYSTEM

Cardiovascular · 11d

Cleared Oct 03, 2002

RADIANALYZER, MODEL 12710

Cardiovascular · 90d

Cleared Sep 24, 2002

PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304

Cardiovascular · 81d

Cleared Dec 18, 2001

RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720

Cardiovascular · 19d

Cleared Jan 11, 2001

RADIANALYZER, MODEL 12710

Cardiovascular · 188d