Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

118 results for "Hologic, Inc."
73–96 of 118
Search insights Median review: 87d Cleared: 98% Top manufacturer: Hologic, Inc. Lead specialty: Radiology
Cleared May 13, 2011
INVADER MTHFR 677
K100987 · OMM
Hologic, Inc.
Pathology · 399d
Cleared Apr 25, 2011
INVADER MTHFR 1298
K100496 · OMM
Hologic, Inc.
Pathology · 427d
Cleared Mar 16, 2011
NHANES WHOLE BODY DXA REFERENCE DATABASE
K103265 · KGI
Hologic, Inc.
Radiology · 132d
Cleared Feb 02, 2011
SECURVIEW DX DIAGNOSTIC WORKSTATION
K103385 · LLZ
Hologic, Inc.
Radiology · 76d
Cleared Jan 07, 2011
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
K103512 · IZH
Hologic, Inc.
Radiology · 38d
Cleared Dec 02, 2010
SECRMARK BIOPSY SITE MARKING SYSTEM
K102768 · NEU
Hologic, Inc.
General & Plastic Surgery · 69d
Cleared Apr 06, 2010
DIGITAL SPOT MAMMOGRAPHY SYSTEM
K100692 · IZH
Hologic, Inc.
Radiology · 27d
Cleared Aug 27, 2009
MAMMOSITE MULTI LUMEN
K092405 · JAQ
Hologic, Inc.
Radiology · 21d
Cleared Jul 02, 2009
MAMMOSITE II RADIATION THERAPY SYSTEM
K091378 · JAQ
Hologic, Inc.
Radiology · 52d
Cleared Jun 04, 2009
R2 DIGITALNOW HD(DIGITALNOW HD)
K091368 · LLZ
Hologic, Inc.
Radiology · 27d
Cleared Sep 12, 2008
QUANTRA
K082483 · LLZ
Hologic, Inc.
Radiology · 15d
Cleared Sep 02, 2008
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER,...
K080711 · KGI
Hologic, Inc.
Radiology · 173d
Cleared May 09, 2008
MAMMOSITE CAVITY EVALUATION DEVICE
K081179 · JAQ
Hologic, Inc.
Radiology · 14d
Cleared Mar 28, 2008
APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS
K072847 · KGI
Hologic, Inc.
Radiology · 176d
Cleared Dec 21, 2007
IMAGECHECKER CT CAD SOFTWARE SYSTEM
K043617 · OEB
Hologic, Inc.
Radiology · 25d
Cleared Aug 18, 2006
SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003
K062107 · LLZ
Hologic, Inc.
Radiology · 25d
Cleared Jul 28, 2006
HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE...
K061561 · KGI
Hologic, Inc.
Radiology · 53d
Cleared Apr 24, 2006
IVA (MXA II SOFTWARE OPTION)
K060111 · KGI
Hologic, Inc.
Radiology · 97d
Cleared May 13, 2005
FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
K051025 · JAA
Hologic, Inc.
Radiology · 21d
Cleared Oct 29, 2004
INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
K042480 · KGI
Hologic, Inc.
Radiology · 46d
Cleared Aug 11, 2004
PEDIATRIC REFERENCE DATABASE
K041266 · KGI
Hologic, Inc.
Radiology · 91d
Cleared Aug 09, 2004
SECURVIEW DX SOFTCOPY WORKSTATION
K041555 · LLZ
Hologic, Inc.
Radiology · 60d
Cleared Apr 23, 2004
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
K040884 · IZH
Hologic, Inc.
Radiology · 18d
Cleared Nov 05, 2003
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
K033224 · KGI
Hologic, Inc.
Radiology · 30d