Medical Device Manufacturer · US , Liverpool , NY

Infimed, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1993

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Infimed, Inc. Radiology ✕

14 devices

1-14 of 14

Cleared Aug 10, 2011

I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)

Radiology · 13d

Cleared Jun 10, 2011

I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)

Radiology · 29d

Cleared Mar 17, 2011

NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM

Radiology · 115d

Cleared Jul 23, 2010

INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5

Radiology · 22d

Cleared Mar 16, 2010

I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5

Radiology · 167d

Cleared Feb 12, 2002

ORION DIGITAL IMAGING SYSTEM

Radiology · 193d

Cleared Mar 31, 2000

Radiology · 256d

Cleared Nov 09, 1999

STINGRAY DR, MODEL 1

Radiology · 82d

Cleared Oct 07, 1999

CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000

Radiology · 66d

Cleared Sep 11, 1997

INFIMED DENTAL SYSTEM

Radiology · 444d

Cleared Sep 27, 1996

Radiology · 53d

Cleared Jul 31, 1996

Radiology · 91d

Cleared Apr 22, 1996

Radiology · 77d

Cleared Nov 03, 1993

QL MULTIPULSE 2048

Radiology · 119d