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<TITLE>Filed by Bowne Pure Compliance</TITLE>
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<P style="font-size: 14pt" align="center"><B>UNITED STATES<BR>
SECURITIES AND
EXCHANGE COMMISSION<BR>
<FONT style="font-size: 12pt">Washington, D.C. 20549
</FONT></B>

<P style="font-size: 18pt" align="center"><B>FORM 8-K</B>

<P style="font-size: 12pt" align="center"><B>CURRENT REPORT<BR>
Pursuant to
Section 13 or 15(d) of the Securities Exchange Act of 1934</B>

<P style="font-size: 10pt" align="center"><B>Date of Report (Date of earliest
event reported): October 20, 2008</B>


<P style="font-size: 24pt" align="center"><B>HEARTWARE LIMITED<BR>
</B><FONT
style="font-size: 10pt">(Exact name of registrant as specified in its charter)
</FONT>
<TABLE style="font-size: 10pt; text-align: center" cellspacing="0"
cellpadding="0" width="100%" border="0">

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  <TD width="32%">&nbsp;</TD>
  <TD width="1%">&nbsp;</TD>
  <TD width="33%">&nbsp;</TD>
  <TD width="1%">&nbsp;</TD>
  <TD width="32%">&nbsp;</TD>
 </TR>
 <TR valign="bottom">
  <TD style="border-bottom: #000000 1px solid"><B>State of Victoria,
Australia</B></TD>
  <TD>&nbsp;</TD>
  <TD style="border-bottom: #000000 1px solid"><B>000-52595</B></TD>
  <TD>&nbsp;</TD>
  <TD style="border-bottom: #000000 1px solid"><B>98-0498958</B></TD>
 </TR>
 <TR valign="top">
  <TD>(State or other Jurisdiction of Incorporation)</TD>
  <TD>&nbsp;</TD>
  <TD>(Commission File Number)</TD>
  <TD>&nbsp;</TD>
  <TD>(IRS Employer Identification No.)</TD>
 </TR>

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cellpadding="0" width="100%" border="0">

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  <TD width="49%">&nbsp;</TD>
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  <TD width="49%">&nbsp;</TD>
 </TR>
 <TR valign="bottom">
  <TD style="border-bottom: #000000 1px solid"><B>Level 57<BR>
MLC
Centre<BR>
19-29 Martin Place<BR>
Sydney NSW 2000<BR>
Australia<BR>
</B></TD>
  <TD>&nbsp;</TD>
  <TD style="border-bottom: #000000 1px solid"><B>&nbsp;</B></TD>
 </TR>
 <TR valign="top">
  <TD>(Address of Principal Executive Offices)</TD>
  <TD>&nbsp;</TD>
  <TD>(Zip Code)</TD>
 </TR>

</TABLE>


<P style="font-size: 10pt" align="center">Registrant&#8217;s telephone number,
including area code: <B>+61 2 9238 2064</B>
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cellpadding="0" width="30%" border="0">

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  <TD style="border-bottom: #000000 1px solid" nowrap><B>&nbsp;</B></TD>
 </TR>
 <TR>
  <TD nowrap>(Former name or former address if changed since last report.)</TD>
 </TR>

</TABLE>


<P style="font-size: 10pt" align="left">Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions:

<P style="font-size: 10pt" align="left"><FONT face="Wingdings">o</FONT> Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)<BR>
<BR>
<FONT face="Wingdings">o</FONT> Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)<BR>
<BR>
<FONT
face="Wingdings">o</FONT> Pre-commencement communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))<BR>
<BR>
<FONT
face="Wingdings">o</FONT> Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))<BR>


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<P style="font-size: 10pt" align="justify"><B>Item&nbsp;7.01 Regulation&nbsp;FD
Disclosure</B>

<P style="font-size: 10pt" align="justify">On October&nbsp;20, 2008, HeartWare
Limited announced, via an Australian Securities Exchange (&#8220;ASX&#8221;)
announcement, that it has received a Certificate of Registration certifying
that the Company&#8217;s Quality Management System complies with the
requirements of ISO 13485:2003.

<P style="font-size: 10pt" align="justify">A copy of the full ASX announcement
is attached as an exhibit.

<P style="font-size: 10pt" align="justify"><B>Item&nbsp;9.01 Financial
Statements and Exhibits</B>

<P style="font-size: 10pt" align="justify">(d)&nbsp;Exhibits

<P style="font-size: 10pt" align="justify">99.1 HeartWare Limited ASX
announcement dated October&nbsp;20, 2008

<P style="font-size: 10pt" align="center"><B>SIGNATURES</B>

<P style="font-size: 10pt" align="justify">Pursuant to the requirements of the
Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned hereunto duly authorized.
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  <TD>&nbsp;</TD>
  <TD valign="top" align="left" colspan="3">HeartWare Limited</TD>
 </TR>
 <TR valign="bottom">
  <TD valign="top">
<DIV style="margin-left: 0px; text-indent: 0px"><BR>Date: October&nbsp;20, 2008
</DIV>
</TD>
  <TD>&nbsp;</TD>
  <TD valign="top" align="left"><BR>By: </TD>
  <TD>&nbsp;</TD>
  <TD valign="top" align="left"><BR>/s/ David McIntyre</TD>
 </TR>
 <TR style="font-size: 1px">
  <TD valign="top">
<DIV style="margin-left: 0px; text-indent: 0px">&nbsp;</DIV>
</TD>
  <TD>&nbsp;</TD>
  <TD valign="top" align="left">&nbsp;</TD>
  <TD>&nbsp;</TD>
  <TD style="border-top: #000000 1px solid" valign="top"
align="left">&nbsp;</TD>
 </TR>
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  <TD valign="top">
<DIV style="margin-left: 0px; text-indent: 0px">&nbsp;</DIV>
</TD>
  <TD>&nbsp;</TD>
  <TD valign="top" align="left">&nbsp;</TD>
  <TD>&nbsp;</TD>
  <TD valign="top" align="left">Name: David McIntyre</TD>
 </TR>
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  <TD valign="top">
<DIV style="margin-left: 0px; text-indent: 0px">&nbsp;</DIV>
</TD>
  <TD>&nbsp;</TD>
  <TD valign="top" align="left">&nbsp;</TD>
  <TD>&nbsp;</TD>
  <TD valign="top" align="left">Title: Chief Financial Officer and Chief Business Officer</TD>
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<P style="font-size: 10pt" align="center">&nbsp;

<P style="display: none; font-size: 10pt" align="center">2
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{"company-data": {"conformed-name": "HeartWare LTD", "cik": "0001389072", "assigned-sic": "3841", "irs-number": "980498958", "state-of-incorporation": "C3", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "8-K", "act": "34", "file-number": "000-52595", "film-number": "081131294"}, "business-address": {"street1": "3351 EXECUTIVE WAY", "city": "MIRAMAR", "state": "FL", "zip": "33025", "phone": "954-874-1400"}, "mail-address": {"street1": "3351 EXECUTIVE WAY", "city": "MIRAMAR", "state": "FL", "zip": "33025"}}
Filed by Bowne Pure Compliance
UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to
Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest
event reported): October 20, 2008
HEARTWARE LIMITED
(Exact name of registrant as specified in its charter)
State of Victoria,
Australia
000-52595
98-0498958
(State or other Jurisdiction of Incorporation)
(Commission File Number)
(IRS Employer Identification No.)
Level 57
MLC
Centre
19-29 Martin Place
Sydney NSW 2000
Australia
(Address of Principal Executive Offices)
(Zip Code)
Registrant's telephone number,
including area code:
+61 2 9238 2064
(Former name or former address if changed since last report.)
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions:
o
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 7.01 Regulation FD
Disclosure
On October 20, 2008, HeartWare
Limited announced, via an Australian Securities Exchange ("ASX")
announcement, that it has received a Certificate of Registration certifying
that the Company's Quality Management System complies with the
requirements of ISO 13485:2003.
A copy of the full ASX announcement
is attached as an exhibit.
Item 9.01 Financial
Statements and Exhibits
(d) Exhibits
99.1 HeartWare Limited ASX
announcement dated October 20, 2008
SIGNATURES
Pursuant to the requirements of the
Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned hereunto duly authorized.
HeartWare Limited
Date: October 20, 2008
By:
/s/ David McIntyre
Name: David McIntyre
Title: Chief Financial Officer and Chief Business Officer