Manufacturer 

Click HERE to see examples of search criteria.

This search locates matches anywhere in the manufacturer name based on submission in the manufacturer block on the search page. 

For best results, enter only a portion of the manufacturer's name for which you want to search (e.g., bio, diag, image, pack, and smith). 

Default Value - When no manufacturer name is specified, the search returns the full list of manufacturers that have reported Y2K status. 

Click HERE to see examples of search criteria. 

Include Matches from Historical Data

By selecting Yes, the historical data is selected for the manufacturer name specified above. Please be aware that searching the historical information will take significantly longer (30 seconds).

Default Value - No, historical data will not be included for matches to the manufacturer name.

Type of Submission

Select one of the following submission types: 

• All Records - Returns all the manufacturers that have reported any type of Y2K status; OR 
• Products Do Not Use a Date - Returns manufacturers that have reported their Y2K status to be, "All Products Do Not Use a Date"; OR 
• Products that are Y2K Compliant - Returns manufacturers that have reported individual products that are Y2K compliant; OR 
• Products With Date-Related Problems - Returns manufacturers that have reported their Y2K status to be, "Products With Date Related Problem". Information about specific products, models, date-related problem, and how the problem will be resolved is provided. Manufacturers reporting Product Problem Information is only for those products that the manufacturer has determined or is currently assessed with date-related problems (including minor problems); OR 
• Product Status Is on the Manufacturer's Web Page - Returns manufacturers that have reported their Y2K status to be, "Product Status Specified on a Web Page"; OR  
• No Information is Available from Manufacturer - Returns manufacturers that have been identified and contacted by the FDA to potentially have Y2K product problems. These manufacturers have not responded to the requests for Y2K status. 

Default Value - All Records

Submissions Received On OR After

Select Month, Day, and/or Year to return manufacturers that have reported Y2K status information on or after a specific date. 

Default Value - All submissions received since February 1998.

Number of Items to Display

Select the number of manufacturers to display on the results page. You can display 10, 25, 50, OR 100 on the results page. 

Default Value - 10 manufacturers per results page.

Manufacturer 

Click HERE to see examples of search criteria.

This search locates matches anywhere in the manufacturer name based on submission in the manufacturer block on the search page. 

For best results, enter only a portion of the manufacturer's name for which you want to search (e.g., bio, diag, image, pack, and smith). 

Default Value - When no manufacturer name is specified, the search returns the full list of manufacturers that have reported Y2K status. 

Click HERE to see examples of search criteria. 

Trade/Brand Name

Commonly used name that identifies the product (i.e. the name that appears on the product level).

Model Name/Number

Model number or range of numbers associated with the product that uniquely identifies it.

Include Matches from Historical Data

By selecting Yes, the historical data is selected for the manufacturer name specified above. Please be aware that searching the historical information will take significantly longer (30 seconds).

Default Value - No, historical data will not be included for matches to the manufacturer name.

Product Classification Keyword

The FDA Product Classification Name to which this product belongs. 

By entering a keyword and clicking Refresh, the select box in the lower frame is populated with product classification information. You will then be able to select one or more product classifications to include in your search criteria. To select the product classifications one by one, hold the CTRL key on the keyboard while you make your selection. To choose a continuous block of classification names, hold the SHIFT key on the keyboard while you make your selection. 

To clear your selections, click the Clear All Selections button. For best results, enter only a portion of the classification name for which you want to search (e.g., bio, oxy, acid).

If no items found based on your criteria, then a message will appear stating that – 

"No matches to Keyword found. Change the criteria specified above."

Type of Submission

Select one of the following submission types: 

• All Records - Returns all the manufacturers that have reported any type of Y2K status; OR 
• Products Do Not Use a Date - Returns manufacturers that have reported their Y2K status to be, "All Products Do Not Use a Date"; OR 
• Products that are Y2K Compliant - Returns manufacturers that have reported individual products that are Y2K compliant; OR 
• Products With Date-Related Problems - Returns manufacturers that have reported their Y2K status to be, "Products With Date Related Problem". Information about specific products, models, date-related problem, and how the problem will be resolved is provided. Manufacturers reporting Product Problem Information is only for those products that the manufacturer has determined or is currently assessed with date-related problems (including minor problems); OR 
• Product Status Is on the Manufacturer's Web Page - Returns manufacturers that have reported their Y2K status to be, "Product Status Specified on a Web Page"; OR  
• No Information is Available from Manufacturer - Returns manufacturers that have been identified and contacted by the FDA to potentially have Y2K product problems. These manufacturers have not responded to the requests for Y2K status. 

Default Value - All Records

Submissions Received On OR After

Select Month, Day, and/or Year to return manufacturers that have reported Y2K status information on or after a specific date. 

Default Value - All submissions received since February 1998.

Number of Items to Display

Select the number of manufacturers to display on the results page. You can display 10, 25, 50, OR 100 on the results page. 

Default Value - 10 manufacturers per results page.

User Input Search String

Examples of Manufacturer Names Matched

Why?

h

American Healthcare Systems Inc. 

The letter "h" is a contained in all of the listed manufacturer names (i.e., "h" is contained in all of the listed manufacturer names.)

pACK

Barger Packaging Corp. 

The letters "pACK" is a substring of the listed manufacturer names. The search is case-insensitive.

ard

Ardent Product/ION Development 

The string "ard" is a substring of the listed manufacturer names. Had the user not known how to spell "Packard", they could just search on "ard".

hewlett-packard

Hewlett-Packard (HP) Company

The string "hewlett-packard" is a substring of "Hewlett-Packard (HP) Company".

Hewlett packard

(none)

The string "Hewlett packard" does not contain a dash and thus is not a substring of "Hewlett-Packard (HP) Company".

hewlett - packard

(none)

The string "hewlett - packard" contains a dash surrounded by spaces and thus is not a substring of "Hewlett-Packard (HP) Company"

HP

Healthpoint, Ltd. 

The string "HP" is a substring of the manufacturer names listed. The commonly used abbreviation "HP" must be explicitly indicated in the manufacturer name for a match to occur.

H.P.

(none)

The string "H.P." contains two periods which are not included in the abbreviation indicated in the manufacturer name "Hewlett-Packard (HP) Company"

-

A-dec Inc. 

The string "-" is a substring of the manufacturer names listed. Any keyboard character including punctuation marks and numbers are included in the search criteria.

#

In numeric order, the unique number for each of the manufacturers returned based on the search criteria. 

Submission Type

The type of submissions associated with each of the manufacturers returned based on the search criteria.

If the manufacturer has provided a list of individual detailed product information, a link –'  (View individually listed compliant products for Advanced Medical Lasers) ' - will appear below the submission type that will allow you to view these compliant products.

Manufacturer

The name of each manufacturer returned based on the search criteria.

Manufacturer

Name of Manufacturer reporting Y2K status information. 

Division

Name of the Division associated with the Manufacturer, if applicable.

Certification Status

Manufacturer reported Y2K status as "All Products Do Not Use a Date".

Y2K Contact Name

Name of the Y2K Contact person.

Y2K Contact Address

Address of the Y2K Contact person.

Y2K Contact City, State/ Province and Postal Code

City, State/Province and Postal Code of the Y2K Contact person.

Y2K Contact Country

Country location of the Y2K Contact person.

Y2K Contact Telephone

Telephone number of the Y2K Contact person.

Y2K Contact FAX

Fax number of the contact person.

Y2K Contact E-Mail

E-Mail Address of the contact person.

Date Added To Database

Date that the submission was entered into the Federal Y2K Biomedical Equipment Clearinghouse database.

Manufacturer

Name of Manufacturer reporting Y2K status information. 

Division

Name of the Division associated with the Manufacturer, if applicable.

Certification Status

Manufacturer reported Y2K status as "All Products are Y2K Compliant'.

Y2K Contact Name

Name of the Y2K Contact person.

Y2K Contact Address

Address of the Y2K Contact person.

Y2K Contact City, State/ Province and Postal Code

City, State/Province and Postal Code of the Y2K Contact person.

Y2K Contact Country

Country location of the Y2K Contact person.

Y2K Contact Telephone

Telephone number of the Y2K Contact person.

Y2K Contact FAX

Fax number of the contact person.

Y2K Contact E-Mail

E-Mail Address of the contact person.

Date Added To Database

Date that the submission was entered into the Federal Y2K Biomedical Equipment Clearinghouse database.

FDA Classification Name or Generic Description

Use the Device Classification as identified in the Device Classification Regulation of 21 CFR 860-892. 

For a product that has not been classified  by the FDA or is scientific research equipment, please provide a generic description in the box below.

Trade or Brand Name

Commonly used name that identifies the product (i.e. the name that appears on the product level).

You can click on each one of these links to view the individual detailed manufacturer information.

Model Number(s)

Model number or range of numbers associated with the product that uniquely identifies it.

Manufacturer

Name of Manufacturer reporting Y2K status information. 

Division

Name of the Division associated with the Manufacturer, if applicable.

FDA Classification Name or Generic Description

Use the Device Classification as identified in the Device Classification Regulation of 21 CFR 860-892. 

For a product that has not been classified  by the FDA or is scientific research equipment, please provide a generic description in the box below.

Trade or Brand Name

Commonly used name that identifies the product (i.e. the name that appears on the product level).

Model Number(s)

Model number or range of numbers associated with the product that uniquely identifies it.

Original Manufacturer

Identify the name of the manufacturer under which this product was originally marketed.

FDA Regulated

Does the FDA regulate this product?

Serial Number(s)

Serial number(s) or range of numbers for compliant products, if applicable.

Software Version Number(s)

Software version number(s) for products with the problem described, if applicable.

Certification Status

Manufacturer reported Y2K status as, "Product is Y2K Compliant" or "All Products are Y2K Compliant".

Y2K Contact Name

Name of the Y2K Contact person.

Y2K Contact Address

Address of the Y2K Contact person.

Y2K Contact City, State/ Province and Postal Code

City, State/Province Postal Code of the Y2K Contact person.

Y2K Contact Country

Country location of the Y2K Contact person.

Y2K Contact Telephone

Telephone number of the Y2K Contact person.

Y2K Contact FAX

Fax number of the Y2K Contact person.

Y2K Contact E-Mail

E-Mail Address of the Y2K Contact person.

Date Added To Database

Date that the submission was entered into the Federal Y2K Biomedical Equipment Clearinghouse database.

Manufacturer

Name of Manufacturer reporting Y2K status information. 

Division

Name of the Division associated with the Manufacturer, if applicable.

Certification Status

Manufacturer reported Y2K status as 'Products with Date-Related Problems'.

Y2K Contact Name

Name of the Y2K Contact person.

Y2K Contact Address

Address of the Y2K Contact person.

Y2K Contact City, State/ Province and Postal Code

City, State/Province and Postal Code of the Y2K Contact person.

Y2K Contact Country

Country location of the Y2K Contact person.

Y2K Contact Telephone

Telephone number of the Y2K Contact person.

Y2K Contact FAX

Fax number of the contact person.

Y2K Contact E-Mail

E-Mail Address of the contact person.

Date Added To Database

Date that the submission was entered into the Federal Y2K Biomedical Equipment Clearinghouse database.

FDA Classification Name or Generic Description

Use the Device Classification as identified in the Device Classification Regulation of 21 CFR 860-892. 

For a product that has not been classified  by the FDA or is scientific research equipment, please provide a generic description in the box below.

Trade or Brand Name

Commonly used name that identifies the product (i.e. the name that appears on the product level). 

You can click on each one of these links to view the individual detailed manufacturer information.

Model Number(s)

Model number or range of numbers associated with the product that uniquely identifies it.

Manufacturer

Name of Manufacturer reporting Y2K status information. 

Division

Name of the Division associated with the Manufacturer, if applicable.

FDA Classification Name or Generic Description

Use the Device Classification as identified in the Device Classification Regulation of 21 CFR 860-892. 

For a product that has not been classified  by the FDA or is scientific research equipment, please provide a generic description in the box below.

Trade or Brand Name

Commonly used name that identifies the product (i.e. the name that appears on the product level).

Original Manufacturer

Manufacturer's name, if different from the reporting Manufacturer.

FDA Regulated

Does FDA regulate this product?

Serial Number(s)

Serial number(s) for products with the problem described, if applicable.

Software Version Number(s)

Software version number(s) for products with the problem described, if applicable.

Date-Related Problem

Description of date-related problem as to: 

• What specifically will happen? 
• How will the date-related problem affect the device's functioning as it relates to its intended use? 
• Does the transition from Dec. 31, 1999, to Jan 1, 2000, or between two other times, introduce unexpected or incorrect performance or functioning of the product? 

User-Action Necessary

If applicable, any other action the user must take in order for the product to function as designed and expected. 

Solution

Solution to be offered by the manufacturer.

Solution Date

Date that the solution will be available from the Manufacturer. A date is NOT required for Minor Problem or Product Obsolete solutions.

Y2K Contact Name

Name of the Y2K Contact person.

Y2K Contact Address

Address of the Y2K Contact person.

Y2K Contact City, State/ Province and Postal Code

City, State/Province and Postal Code of the Y2K Contact person.

Y2K Contact Country

Country location of the Y2K Contact person.

Y2K Contact Telephone

Telephone number of the Y2K Contact person.

Y2K Contact FAX

Fax number of the Y2K Contact person.

Y2K Contact E-Mail

E-Mail Address of the Y2K Contact person.

Date Added To Database

Date that the submission was entered into the Federal Y2K Biomedical Equipment Clearinghouse database.

Manufacturer

Name of Manufacturer reporting Y2K status information. 

Division

Name of the Division associated with the Manufacturer, if applicable.

Product

A manufacturer's name on the results page, flagged with a "†" indicates that this manufacturer's Web site has been verified to contain Y2K product problem information.

URL Address

URL Address that points to the manufacturer's Web site providing Y2K product information.

Y2K Contact Name

Name of the Y2K Contact person.

Y2K Contact Address

Address of the Y2K Contact person.

Y2K Contact City, State/Province and Postal Code

City, State/Province Postal Code of the Y2K Contact person.

Y2K Contact Country

Country location of the Y2K Contact person.

Y2K Contact Telephone

Telephone number of the Y2K Contact person.

Y2K Contact FAX

Fax number of the Y2K Contact person.

Y2K Contact E-Mail

E-Mail Address of the Y2K Contact person.

Date Added To Database

Date that the submission was entered into the Federal Y2K Biomedical Equipment Clearinghouse database.

Manufacturer

Name of Manufacturer reporting Y2K status information. 

If there is Corporate History information available for the reporting manufacturer, there will be an active link under the manufacturer name called View Corporate History. Click on the link for details about the reporting manufacturers corporate history.

Division

Name of the Division associated with the Manufacturer, if applicable.

Certification Status

Manufacturer has not responded to the requests for Y2K status information from the FDA. 

Y2K Contact Name

Name of the Y2K Contact person.

Y2K Contact Address

Address of the Y2K Contact person.

Y2K Contact City, State/Province Postal Code

City, State/Province Postal Code of the Y2K Contact person.

Y2K Contact Country

Country location of the Y2K Contact person.

Y2K Contact Telephone

Telephone number of the Y2K Contact person.

Y2K Contact FAX

Fax number of the Y2K Contact person.

Y2K Contact E-Mail

E-Mail Address of the Y2K Contact person.

Date Added To Database

Date that the submission was entered into the Federal Y2K Biomedical Equipment Clearinghouse database.

Name

Historical Name ("Identified Manufacturer") for Reporting Manufacturer.

Relationship to Reporting Manufacturer

Description of how the reporting manufacturer is related to the Historical Name.

Comments

Additional detailed information related to the corporate history for the reporting manufacturer and its Historical Names.

Relationship Reason

Definition

Example

Acronym/Abbreviation

Well-known or common alphabetical or numeric characters that serve as a recognizable alternative for the manufacturer name.

3M - Minnesota Mining and Manufacturing

Distributor for Manufacturer

An independent company which distributes products for the reporting manufacturer and does not manufacture biomedical equipment of its own.

Ela*Angeion is a distributor for ELA Medical.

Division

A subset of a manufacturer which may or may not operate independently and may or may not report the same Y2K compliance status.

Ethicon Inc., a division of Johnson & Johnson Inc.

Former Name of Manufacturer

The identified name is a prior name of the reporting manufacturer. This may be due to a sale, merger or just a name change.

Miles Inc., changed its name to Bayer Corp.

Former Name Prior to Merger

A former name of one of the companies involved in a merger.

Beckman Instruments is a former name of Beckman Coulter.

Former Parent

The identified manufacturer formerly owned the reporting manufacturer.

Critikon - formerly owned by Johnson & Johnson inc.

Former Subsidiary or Division of Manufacturer; Sold to (See comments)

A division or Subsidiary that was sold to another company. When available, the purchasing company is listed in the history comments.

Grason Stadler Inc., formerly a part of Welch Allyn was sold to Nicolet Biomedical Inc.

Manufacturer Purchased Company

The reporting manufacturer purchased the identified manufacturer.

Johnson & Johnson Inc purchased Innotech.

Manufacturer Purchased Partial Product Line/Old Company Still Exists (See Comments)

The reporting manufacturer purchased one or more products from the identified manufacturer; this company still manufactures products. The reporting manufacturer is only submitting the Y2K compliance status for the identified manufacturer product lines listed in the history comments. The identified manufacturer's Y2K status may or may not be available in the status database.

Alcon Laboratories Inc., purchased a partial product line of CooperVision Inc. CooperVision Inc., appears in the Y2K status database as a separate submission.

Manufacturer Purchased Partial Product Line/Old Company does not exist (See Comments)

The reporting manufacturer purchased one or more products from the identified manufacturer; and /or this company no longer manufactures products. The reporting manufacturer is only submitting the Y2K compliance status for the identified manufacturer product lines listed in the history comments. The status of the identified manufacturer's remaining products may or may not be known.

ConMed/Aspen Labs purchased a partial product line from Baird Inc. At this time, we have no information on the remaining product lines of Baird Inc.

Parent

The identified manufacturer owns the reporting manufacturer.

Trex Madical is a parent to Lorad Inc.

See Comments

The comments section is used in cases where either the relationship is not identified within the 14 categories or where a relationship needs a further explanation.

Boston Scientific

Sister Company

The same company - as the reporting manufacturer - owns the identified company. Their Y2K status may or may not be the same.

Ethicon Inc. and Ethicon endo-Surgery are owned by Johnson & Johnson Inc

Subsidiary

The reporting manufacturer owns the identified manufacturer; however, the reporting manufacturer's compliance status may or may not apply to the identified manufacturer.

Johnson & Johnson Medical, an Ethicon Inc. Company.