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<SEC-DOCUMENT>0001096906-04-000496.txt : 20041116
<SEC-HEADER>0001096906-04-000496.hdr.sgml : 20041116
<ACCEPTANCE-DATETIME>20041116160523
ACCESSION NUMBER:		0001096906-04-000496
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20041116
ITEM INFORMATION:		Other Events
FILED AS OF DATE:		20041116
DATE AS OF CHANGE:		20041116

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			UTAH MEDICAL PRODUCTS INC
		CENTRAL INDEX KEY:			0000706698
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		IRS NUMBER:				870342734
		STATE OF INCORPORATION:			UT
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-12575
		FILM NUMBER:		041149637

	BUSINESS ADDRESS:	
		STREET 1:		7043 S 300 WEST
		CITY:			MIDVALE
		STATE:			UT
		ZIP:			84047
		BUSINESS PHONE:		8015661200
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>utahmedical8k111604.txt
<TEXT>
                                  UNITED STATES
                       SECURITIES AND EXCHANGE COMMISSION
                             Washington, D.C. 20549

                                    FORM 8-K

                       Pursuant to Section 13 or 15(d) of
                       The Securities Exchange Act of 1934



       Date of Report (date of earliest event reported): November 16, 2004


                           Commission File No. 0-11178
                                               -------


                           UTAH MEDICAL PRODUCTS, INC.
                           ---------------------------
             (Exact name of Registrant as specified in its charter)


                  UTAH                                  87-0342734
      -------------------------------                ------------------
      (State or other jurisdiction of                (I.R.S. Employer
       incorporation or organization)                Identification No.)


                               7043 South 300 West
                               Midvale, Utah 84047
                     Address of principal executive offices


Registrant's telephone number:      (801) 566-1200
                                    --------------



<PAGE>



- --------------------------------------------------------------------------------
                             ITEM 8.01 OTHER EVENTS
- --------------------------------------------------------------------------------


On November 16, 2004, Utah Medical Products, Inc. issued a press release further
commenting on the FDA complaint and FDA comments. A copy of the press release is
attached hereto as Exhibit 99.1


- --------------------------------------------------------------------------------
                                   SIGNATURES
- --------------------------------------------------------------------------------



Pursuant to the requirements of the Securities Exchanges Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.


                                            UTAH MEDICAL PRODUCTS, INC.
                                            ---------------------------
                                            REGISTRANT


Date:          11/16/04                     By:    /s/ Kevin L. Cornwell
     -----------------------------                 ---------------------
                                                       Kevin L. Cornwell
                                                       CEO




- --------------------------------------------------------------------------------

                                  EXHIBIT INDEX


Index
Number         Description
- ------         -----------

99.1           Press release issued November 16, 2004: UTMD Further Comments on
               FDA Complaint and FDA Comments






</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>utahmedicalex99-111604.txt
<TEXT>
                                  EXHIBIT 99.1

Salt Lake City, Utah - Utah Medical Products, Inc. (Nasdaq: UTMD) is a defendant
in a complaint filed by the Food and Drug Administration (FDA or Agency) on
August 9, 2004 with the U.S. District Court in Salt Lake City, alleging
violations of the Quality System Regulation (QSR). Compliance with the
requirements of this regulation "are intended to ensure that finished devices
will be safe and effective..."

On Tuesday, November 9, FDA enforcement official Larry Spears testified under
oath that the FDA is not claiming, in the lawsuit, that UTMD's devices are
either unsafe or ineffective. UTMD is pleased that the FDA agrees with UTMD's
statements following the August 10, 2004 FDA press release that neither the
complaint nor any direct FDA communications to UTMD has identified or suggested
any issue relating to the safety or effectiveness of UTMD devices.

UTMD provides the following verbatim excerpts from the testimony for the benefit
of shareholders, customers and other interested parties. The full text of the
deposition is available upon request. The questions (denoted "Q") are being
asked by UTMD legal counsel. The answers (denoted "A") are provided by Mr.
Spears.

          Q. I'm going to assume that your answers are a complete and exhaustive
          statement of the Agency's position unless you specifically state
          otherwise. Do you understand that?
                  A.    Yes.
                                     ****

          Q. You knew as of August 11, 2004, that the FDA is not aware of any
          harm linked to Utah Medical devices, correct?
                  A.    That's correct.

         Q. I would like to show you what's been marked as Exhibit 13. Exhibit
         13 is a newspaper article in the Salt Lake Tribune on August 11, 2004.
         I'd like to direct you to the second page of Exhibit 13. The third
         paragraph down refers to your name and it says, "Spears conceded the
         FDA is making no allegations the company's products are unsafe or that
         any imminent public health risk exists." Is that an accurate of your --
         accurate reflection of your statement to the Salt Lake Tribune on
         August 11, 2004?
                  A.    Yes.

         Q. So it is, in fact, true in this case that the FDA does not allege
         that Utah Medical has manufactured or distributed any unsafe product,
         correct?
                  A.    That's correct.

         Q. And it's also true in this case the FDA has not alleged that anyone
         has been injured by any product manufactured or distributed by Utah
         Medical, correct?
                  A.    That's correct.

          Q. And the FDA does not allege that Utah Medical has manufactured or
          distributed any defective product, correct?
                  A. That's correct.

          Q. And the FDA does not allege that Utah Medical has manufactured or
          distributed any ineffective product, correct?
                  A.    That's correct.



<PAGE>



          Q. And the FDA has authority to immediately seize products where the
          public health is threatened but it has not done that here, correct?
                  A.    That's correct.

          Q. And the FDA has authority to require recalls of devices if the
          public health is threatened but that has not been done here, correct?
                  A. That's correct.

          Q. And the agency could have sought preliminary injunctive relief if
          there were a public health threat, but that was not done in this case
          either; is that correct?
                  A.    That's correct.

According to UTMD CEO Kevin Cornwell, "Larry Spears' testimony confirms the very
essence of UTMD's compliance with the QSR, namely, manufacture and distribution
of safe and effective devices year after year, year after year."

Users of UTMD devices can take comfort in the quality and performance of UTMD's
devices. UTMD maintains support for the quality, performance, safety and
effectiveness of devices in distribution as these are manufactured daily by
dedicated employees complying with procedures that have been verified by
independent experts. Coupled with ISO13485 Certification, these facts are
continuing verification of the superiority of UTMD quality systems.

Utah Medical Products, Inc., with particular interest in health care for women
and their babies, develops, manufactures, assembles and markets a broad range of
well-established, proven safe and effective, disposable and reusable specialty
medical devices.




</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
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