Utah Medical Products, Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
38
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0233-2016Class IIMyelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, includinOctober 16, 2015
Z-1543-2013Class IIDeltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transduJune 4, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K143424UTAH CVX-RIPEAugust 28, 2015
K123310FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)January 23, 2013
K101535BT-CATHJanuary 11, 2011
K063611SALINE/ CONTRAST MEDIA INFUSION CATHETERMay 23, 2007
K001874PERIPHERALLY INSERTED CENTRAL CATHETERSeptember 25, 2000
K000974FOWLER ENDOCURETTE, MODEL CUR-XXXMay 23, 2000
K965245TBDJuly 3, 1997
K970077LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044)May 23, 1997
K955663ABC IN-LINE BLOOD SAMPLING KITMarch 17, 1997
K964526LIBERTY RECTAL PELVIC FLOOR EXERCISERFebruary 10, 1997
K961424INTRAN 500July 10, 1996
K960496LIBERTY LITE PFS SYSTEMJune 27, 1996
K955093ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511April 29, 1996
K960255CERAMIC BLADE ELECTRODEMarch 27, 1996
K955443INTRAN PLUSFebruary 20, 1996
K954619CORDGUARD IIDecember 21, 1995
K952981FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VACAugust 28, 1995
K943448LUMINApril 11, 1995
K951032FINESS I (DERMATOLOGIC APPLICATION)April 6, 1995
K943250LIBERTYFebruary 9, 1995