Company ยท US
Utah Medical Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2015. Name variants (Inc, Corp, punctuation) are merged.
38510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | 4 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 4 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 |
| HFN | Transducer, Pressure, Intrauterine | 3 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 2 |
| KXO | Monitor, Pressure, Intrauterine | 2 |
| LKF | Cannula, Manipulator/Injector, Uterine | 2 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 |
| BXX | Calibrator, Pressure, Gas | 1 |
| BZG | Spirometer, Diagnostic | 1 |
| CBT | Arterial Blood Sampling Kit | 1 |
| FOG | Hood, Oxygen, Infant | 1 |
| FYD | Apparatus, Exhaust, Surgical | 1 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 1 |
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 1 |
| HRX | Arthroscope | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2015 | K143424 | UTAH CVX-RIPE Utah Medical Products, Inc. | PFJ |
| Jan 23, 2013 | K123310 | FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) Utah Medical Products, Inc. | GEI |
| Jan 11, 2011 | K101535 | BT-CATH Utah Medical Products, Inc. | OQY |
| May 23, 2007 | K063611 | SALINE/ CONTRAST MEDIA INFUSION CATHETER Utah Medical Products, Inc. | LKF |
| Sep 25, 2000 | K001874 | PERIPHERALLY INSERTED CENTRAL CATHETER Utah Medical Products, Inc. | LJS |
| May 23, 2000 | K000974 | FOWLER ENDOCURETTE, MODEL CUR-XXX Utah Medical Products, Inc. | HHK |
| Jul 3, 1997 | K965245 | TBD Utah Medical Products, Inc. | HGI |
| May 23, 1997 | K970077 | LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) Utah Medical Products, Inc. | KPI |
| Mar 17, 1997 | K955663 | ABC IN-LINE BLOOD SAMPLING KIT Utah Medical Products, Inc. | CBT |
| Feb 10, 1997 | K964526 | LIBERTY RECTAL PELVIC FLOOR EXERCISER Utah Medical Products, Inc. | KPI |
| Jul 10, 1996 | K961424 | INTRAN 500 Utah Medical Products, Inc. | HFN |
| Jun 27, 1996 | K960496 | LIBERTY LITE PFS SYSTEM Utah Medical Products, Inc. | KPI |
| Apr 29, 1996 | K955093 | ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511 Utah Medical Products, Inc. | HGI |
| Mar 27, 1996 | K960255 | CERAMIC BLADE ELECTRODE Utah Medical Products, Inc. | GEI |
| Feb 20, 1996 | K955443 | INTRAN PLUS Utah Medical Products, Inc. | HFN |
| Dec 21, 1995 | K954619 | CORDGUARD II Utah Medical Products, Inc. | KNA |
| Aug 28, 1995 | K952981 | FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC Utah Medical Products, Inc. | FYD |
| Apr 11, 1995 | K943448 | LUMIN Utah Medical Products, Inc. | LKF |
| Apr 6, 1995 | K951032 | FINESS I (DERMATOLOGIC APPLICATION) Utah Medical Products, Inc. | GEI |
| Feb 9, 1995 | K943250 | LIBERTY Utah Medical Products, Inc. | KPI |
| Dec 12, 1994 | K941251 | FINESSE IEC/601 Utah Medical Products, Inc. | HGI |
| May 26, 1993 | K920152 | BUBBLE TOCO Utah Medical Products, Inc. | HFM |
| Sep 18, 1991 | K905263 | UTAH ESSU Utah Medical Products, Inc. | HGI |
| Jun 25, 1991 | K905092 | NEUROMUSCULAR TRANSMISSION MONITOR Utah Medical Products, Inc. | BXN |
| Jun 19, 1991 | K905563 | INTRAN PLUS Utah Medical Products, Inc. | KXO |
| Mar 29, 1991 | K905830 | COMBO FETAL SCALP ELECTRODE/LEGPLATE Utah Medical Products, Inc. | HGP |
| Aug 21, 1990 | K901237 | GLOVE LEAK DETECTOR Utah Medical Products, Inc. | LDQ |
| Mar 20, 1987 | K864090 | SHELF LIFE CHANGE OF STERILE DEVICES Utah Medical Products, Inc. | DRS |
| Feb 26, 1987 | K862873 | IUC - INTRAUTERINE CATHETER Utah Medical Products, Inc. | KXO |
| Jul 17, 1986 | K861783 | DISPOSABLE STOPCOCK Utah Medical Products, Inc. | DTL |
| Feb 10, 1986 | K854960 | DISPOSABLE MANIFOLD Utah Medical Products, Inc. | DTL |
| Apr 29, 1985 | K850029 | UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL Utah Medical Products, Inc. | BXX |
| Mar 25, 1985 | K842352 | PRESSURE MONITORING KIT Utah Medical Products, Inc. | DRS |
| Mar 25, 1985 | K841788 | UTAH DISPOSABLE PRESSURE TRANSDUCER Utah Medical Products, Inc. | DRS |
| Dec 3, 1982 | K822560 | IRRIGATION SET Utah Medical Products, Inc. | NBH |
| Jul 22, 1982 | K821672 | PROFLEX Utah Medical Products, Inc. | HRX |
| Dec 5, 1979 | K792144 | DISPOSA-HOOD Utah Medical Products, Inc. | FOG |
| Aug 10, 1979 | K791177 | DISPIRO Utah Medical Products, Inc. | BZG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2015 | Utah Medical Products, Inc 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, Terminated |
KDD | K821814 |
| Jun 13, 2013 | Utah Medical Products, Inc 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 Terminated |
DRS | None listed |
| Sep 11, 2008 | Utah Medical Products, Inc 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, Sin Terminated |
HFN | K905563 K955443 +1 |