Medical Device Manufacturer · US , Mchenry , IL

Amersham Corp. - FDA 510(k) Cleared Devices

94 submissions · 94 cleared · Since 1976

94

Total

94

Cleared

0

Denied

FDA 510(k) Regulatory Record - Amersham Corp. Radiology ✕

11 devices

1-11 of 11

Cleared Jul 09, 1990

GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415

Radiology · 76d

Cleared Jul 09, 1990

GADOLINIUM-153 BONE DENSITOMETER SOURCES

Radiology · 76d

Cleared Jul 09, 1990

GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)

Radiology · 76d

Cleared Jul 09, 1990

GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)

Radiology · 76d

Cleared Sep 29, 1989

CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD

Radiology · 74d

Cleared Feb 06, 1989

HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN

Radiology · 19d

Cleared Sep 09, 1981

GOLD(AU 195) SPOT MARKER SOURCES

Radiology · 29d

Cleared Sep 09, 1981

GOLD(AU 195) GAMMA CAMERA CHECK(FLOOD)

Radiology · 29d

Cleared May 28, 1980

DOSE CALIBRATION REF. SOURCES

Radiology · 41d

Cleared Mar 25, 1980

CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.

Radiology · 42d

Cleared Mar 10, 1977

MONITOR, RADIOISOTOPE, MODEL 9273A

Radiology · 8d