Imagyn Medical Technologies, Inc.

FDA Regulatory Profile

Imagyn Medical Technologies, Inc. appears in FDA public data with 0 recalls, 7 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 4, 2003.

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K032491ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITORSeptember 4, 2003
K012706IM2001 PULSE OXIMETERMarch 7, 2003
K010166IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEMDecember 3, 2001
K991526ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501June 17, 1999
K980096OAC (OPTICAL ASPIRATING CURETTE)May 1, 1998
K980291IMPOWER EXTERNAL VACUUM SYSTEMMarch 11, 1998
K974173ERECAID SYSTEM/STAY EREC SYSTEMFebruary 25, 1998