Utah Medical Products, Inc
Midvale, UT, US
UTAH MEDICAL PRODUCTS, INC. appears in FDA device records in Midvale, UT. FDA records list 38 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 38 510(k) clearances for Utah Medical Products, Inc between 1979 and 2015. The busiest year on record is 1995, with 5. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 2 |
| 1982 | 2 |
| 1985 | 3 |
| 1986 | 2 |
| 1987 | 2 |
| 1990 | 1 |
| 1991 | 4 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 5 |
| 1996 | 5 |
| 1997 | 4 |
| 2000 | 2 |
| 2007 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K143424 | UTAH CVX-RIPE | PFJ | Substantially Equivalent | |
| K123310 | FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) | GEI | Substantially Equivalent | |
| K101535 | BT-CATH | OQY | Substantially Equivalent | |
| K063611 | SALINE/ CONTRAST MEDIA INFUSION CATHETER | LKF | Substantially Equivalent | |
| K001874 | PERIPHERALLY INSERTED CENTRAL CATHETER | LJS | Substantially Equivalent | |
| K000974 | FOWLER ENDOCURETTE, MODEL CUR-XXX | HHK | Substantially Equivalent | |
| K965245 | TBD | HGI | Substantially Equivalent | |
| K970077 | LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) | KPI | Substantially Equivalent | |
| K955663 | ABC IN-LINE BLOOD SAMPLING KIT | CBT | Substantially Equivalent | |
| K964526 | LIBERTY RECTAL PELVIC FLOOR EXERCISER | KPI | Substantially Equivalent | |
| K961424 | INTRAN 500 | HFN | Substantially Equivalent | |
| K960496 | LIBERTY LITE PFS SYSTEM | KPI | Substantially Equivalent | |
| K955093 | ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511 | HGI | Substantially Equivalent | |
| K960255 | CERAMIC BLADE ELECTRODE | GEI | Substantially Equivalent | |
| K955443 | INTRAN PLUS | HFN | Substantially Equivalent | |
| K954619 | CORDGUARD II | KNA | Substantially Equivalent | |
| K952981 | FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC | FYD | Substantially Equivalent | |
| K943448 | LUMIN | LKF | Substantially Equivalent | |
| K951032 | FINESS I (DERMATOLOGIC APPLICATION) | GEI | Substantially Equivalent | |
| K943250 | LIBERTY | KPI | Substantially Equivalent | |
| K941251 | FINESSE IEC/601 | HGI | Substantially Equivalent | |
| K920152 | BUBBLE TOCO | HFM | Substantially Equivalent | |
| K905263 | UTAH ESSU | HGI | Substantially Equivalent | |
| K905092 | NEUROMUSCULAR TRANSMISSION MONITOR | BXN | Substantially Equivalent | |
| K905563 | INTRAN PLUS | KXO | Substantially Equivalent | |
| K905830 | COMBO FETAL SCALP ELECTRODE/LEGPLATE | HGP | Substantially Equivalent | |
| K901237 | GLOVE LEAK DETECTOR | LDQ | Substantially Equivalent | |
| K864090 | SHELF LIFE CHANGE OF STERILE DEVICES | DRS | Substantially Equivalent | |
| K862873 | IUC - INTRAUTERINE CATHETER | KXO | Substantially Equivalent | |
| K861783 | DISPOSABLE STOPCOCK | DTL | Substantially Equivalent | |
| K854960 | DISPOSABLE MANIFOLD | DTL | Substantially Equivalent | |
| K850029 | UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL | BXX | Substantially Equivalent | |
| K842352 | PRESSURE MONITORING KIT | DRS | Substantially Equivalent | |
| K841788 | UTAH DISPOSABLE PRESSURE TRANSDUCER | DRS | Substantially Equivalent | |
| K822560 | IRRIGATION SET | NBH | Substantially Equivalent | |
| K821672 | PROFLEX | HRX | Substantially Equivalent | |
| K792144 | DISPOSA-HOOD | FOG | Substantially Equivalent | |
| K791177 | DISPIRO | BZG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1718873 | 1718873 | UTAH MEDICAL PRODUCTS, INC. | 7043 South 300 West, Midvale, UT 84047 US | 2026 | and 27 more, listed in full below |
| 9616675 | 3003105967 | UTAH MEDICAL PRODUCTS, LTD. | ATHLONE BUSINESS & TECHNOLOGY PARK, ATHLONE CO. Leinster -- IE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBHAccessories, Arthroscopic
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- HGEAmniotome
- FYDApparatus, Exhaust, Surgical
- CBTArterial Blood Sampling Kit
- HRXArthroscope
- IKDCable, Electrode
- BXXCalibrator, Pressure, Gas
- LKFCannula, Manipulator/Injector, Uterine
- JOLCatheter And Tip, Suction
- PFJCatheter, Balloon, Dilation Of Cervical Canal Prior To Labor
- KRACatheter, Continuous Flush
- GBQCatheter, Continuous Irrigation
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FKOCatheter, Peritoneal Dialysis, Single Use
- KOBCatheter, Suprapubic (And Accessories)
- FOSCatheter, Umbilical Artery
- GBMCatheter, Urethral
- BSYCatheters, Suction, Tracheobronchial
- HISCondom
- HHKCurette, Suction, Endometrial (And Accessories)
- KYXDispenser, Liquid Medication
- HGIElectrocautery, Gynecologic (And Accessories)
- HGPElectrode, Circular (Spiral), Scalp And Applicator
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HDBExtractor, Vacuum, Fetal
- FPBFilter, Infusion Line
- FOGHood, Oxygen, Infant
- KNAInstrument, Manual, Specialized Obstetric-Gynecologic
- OQYIntrauterine Tamponade Balloon
- KDDKit, Surgical Instrument, Disposable
- KNHLaparoscopic Contraceptive Tubal Occlusion Device
- KYTLight, Examination, Medical, Battery Powered
- KXOMonitor, Pressure, Intrauterine
- HFMMonitor, Uterine Contraction, External (For Use In Clinic)
- BZGSpirometer, Diagnostic
- KPIStimulator, Electrical, Non-Implantable, For Incontinence
- BXNStimulator, Nerve, Battery-Powered
- KSTSystem, Blood Collection, Vacuum-Assisted, Manual
- DRSTransducer, Blood-Pressure, Extravascular
- HFNTransducer, Pressure, Intrauterine
- BTRTube, Tracheal (W/Wo Connector)
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0233-2016 | Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, a polylined drape, three gauze pads, and one spot bandage. | Utah Medical is conducting a recall of Myelo-Nate CSF Sampling Kit due to an internal post-sterilization inspection that found a sterile finished tray where the seal between the Tyvek lid and the PETG tray on one side of the tray had been compromised. | Class II | Terminated | |
| Z-1543-2013 | Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during invasive blood pressure monitoring of humans and animals. | Utah Medical Products, Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due to complaints related to packaging integrity of the sterile packaged devices. | Class II | Terminated | |
| Z-2200-2008 | Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400, IUP-400S, IUP-450, IUP-450S, IUP-500, IUP-550, IUP-600, IUP-600S, IUP-650, IUP-650S, IUP-700, IUP-750, Sterile, Single Use, Utah Medical Products Inc., 7043 South 300 West, Midvale, Utah 84047. | Possibility of compromised package sterility prior to the expiration date. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain