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Hologic, Inc.

344 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Selenia Dimensions/3Dimensions 3D System (P080003/S006)Hologic, Inc.2018-03-23
Aptima HCV Quant Dx Assay (P160023/S001)Hologic, Inc.2018-02-23
Aptima HBV Quant Assay (P170025)Hologic, Inc.2018-01-23
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S069)Hologic, Inc.2018-01-12
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S068)Hologic, Inc.2017-07-18
Selenia Dimensions 3D System. (P080003/S005)Hologic, Inc.2017-05-23
3Dimensions (P080003/S004)Hologic, Inc.2017-04-20
APTIMA HCV QUANT DX ASSAY (P160023)Hologic, Inc.2017-02-13
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S067)Hologic, Inc.2017-01-10
THINPREP PROCESSOR, (P950039/S035)Hologic, Inc.2016-10-26
SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P080003/S003)Hologic, Inc.2016-07-07
IMAGE CHECKER, IMAGE CHECKER LICENSE (P970058/S027)Hologic, Inc.2016-04-26
RAPID FFN FOR THE TLIIQ SYSTEM (P920048/S011)Hologic, Inc.2016-02-05
THINPREP PROCESSORS (P950039/S034)Hologic, Inc.2016-01-11
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM. (P010013/S066)Hologic, Inc.2015-10-27
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S064)Hologic, Inc.2015-10-22
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S065)Hologic, Inc.2015-10-15
RAPID FFN FOR THE TLIIQ SYSTEM (P920048/S009)Hologic, Inc.2015-06-24
NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM (P010013/S063)Hologic, Inc.2015-06-15
THINPREP IMAGING SYSTEM (P020002/S010)Hologic, Inc.2015-06-02
CERVISTA HPV 16/18 ASSAY (P080015/S012)Hologic, Inc.2015-05-29
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S062)Hologic, Inc.2015-03-19
THINPREP-5000 (P950039/S026)Hologic, Inc.2015-03-02
THINPREP IMAGING SYSTEM (P020002/S009)Hologic, Inc.2015-01-12
THINPREP PROCESSORS (P950039/S032)Hologic, Inc.2014-12-10
THINPREP PROCESSORS (P950039/S031)Hologic, Inc.2014-11-20
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S061)Hologic, Inc.2014-11-12
NOVASURE IMPEDANCE CONTROLLED EDOMETRIAL ABLATION SYSTEM (P010013/S058)Hologic, Inc.2014-10-28
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S060)Hologic, Inc.2014-10-06
THINPREP PROCESSORS (P950039/S030)Hologic, Inc.2014-09-26
THINPREP IMAGING SYSTEM (P020002/S008)Hologic, Inc.2014-09-18
THIN PREP PROCESSORS (P950039/S029)Hologic, Inc.2014-09-12
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM/ ABLATION SYSTEM WITH SURESOUND UTERINE SOUND (P010013/S059)Hologic, Inc.2014-09-09
RAPID FFN CONTROL KIT (P920048/S008)Hologic, Inc.2014-07-24
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S057)Hologic, Inc.2014-06-19
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM, NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL SYSTEM WITH SURE (P010013/S056)Hologic, Inc.2014-06-04
NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM (P010013/S054)Hologic, Inc.2014-05-30
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S055)Hologic, Inc.2014-05-14
CERVISTA HPV HR AND GENFIND KIT (P080014/S018)Hologic, Inc.2014-04-29
THINPREP IMAGING SYSTEM (P020002/S007)Hologic, Inc.2014-04-29
CERVISTA HPV 16/18 (P080015/S009)Hologic, Inc.2014-04-29
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S047)Hologic, Inc.2014-04-25
THINPREP SLIDES (P950039/S028)Hologic, Inc.2014-04-24
NOVASURE MODEL 10 RADIOFREQUENCY CONTROL UNIT (P010013/S051)Hologic, Inc.2014-04-22
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION DEVICE (P010013/S053)Hologic, Inc.2014-03-26
CERVISTA HPV HR TEST (P080014/S019)Hologic, Inc.2014-03-04
CERVISTA HPV 16/18 TEST (P080015/S010)Hologic, Inc.2014-03-04
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S052)Hologic, Inc.2014-02-25
IMAGE CHECKER CAD (P970058/S026)Hologic, Inc.2014-02-10
THINPREP SLIDES (P950039/S027)Hologic, Inc.2014-01-29
CERVISTA HPV HR (P080014/S020)Hologic, Inc.2013-12-03
CERVISTA HPV 16/18 (P080015/S011)Hologic, Inc.2013-12-03
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S050)Hologic, Inc.2013-11-08
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S049)Hologic, Inc.2013-10-10
CERVISTA HPV HR ASSAY (P080014/S017)Hologic, Inc.2013-08-22
NOVASURE IMPEDANCE CONTROLLED ENDOMETERIAL ABALTION SYSTEM (P010013/S048)Hologic, Inc.2013-08-20
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM, & WITH SURESOUND ULTRINE SOUND, NOVASURE RF CONTROLLER 115V (P010013/S046)Hologic, Inc.2013-07-10
SELENIA DIMENSIONS 3D SYSTEM (P080003/S001)Hologic, Inc.2013-05-16
CERVISTA HPV HR, GENFIND DNA EXTRACTION KIT (P080014/S015)Hologic, Inc.2013-04-18
CERVISTA HPV HR ASSAY (P080014/S016)Hologic, Inc.2013-03-15
CERVISTA HPV HR COMPONENTS (P080014/S011)Hologic, Inc.2013-02-04
CERVISTA HPV 16/18 COMPONENTS (P080015/S006)Hologic, Inc.2013-02-04
NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S041)Hologic, Inc.2013-02-01
CERVISTA HPV HR (P080014/S014)Hologic, Inc.2012-12-14
NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S045)Hologic, Inc.2012-11-15
IMAGECHECKER CAD (P970058/S025)Hologic, Inc.2012-09-21
CERVISTA HPV 16/18 (P080015/S008)Hologic, Inc.2012-07-06
CERVISTA HUMAN PAPILLOMA VIRUS (HPV) (P080014/S013)Hologic, Inc.2012-07-03
CERVISTA HPV 16/18 (P080015/S007)Hologic, Inc.2012-05-21
CERVISTA HPV HR (P080014/S012)Hologic, Inc.2012-05-21
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S043)Hologic, Inc.2012-05-03
THINPREP PROCESSOR 2000/3000 SYSTEM (P950039/S024)Hologic, Inc.2012-04-09
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S028)Hologic, Inc.2012-03-28
ADIANA CONTRACEPTION SYSTEM (P070022/S025)Hologic, Inc.2012-03-20
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S026)Hologic, Inc.2012-02-09
REVIEW SCOPE MANUAL (P020002/S006)Hologic, Inc.2012-01-23
CERVISTA HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR) (P080014/S010)Hologic, Inc.2012-01-20
NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S042)Hologic, Inc.2011-12-20
CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION (P080014/S007)Hologic, Inc.2011-12-12
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S024)Hologic, Inc.2011-11-23
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S014)Hologic, Inc.2011-09-06
NOVASURE IMPENDANCE CONROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S039)Hologic, Inc.2011-08-18
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S020)Hologic, Inc.2011-08-09
CERVISTA HPV HR COMPONENTS (P080014/S009)Hologic, Inc.2011-08-02
CERVISTA HPV 16/18 (P080015/S005)Hologic, Inc.2011-08-02
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S021)Hologic, Inc.2011-07-26
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S013)Hologic, Inc.2011-07-05
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S036)Hologic, Inc.2011-06-29
CERVISTA HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR) (P080014/S008)Hologic, Inc.2011-06-23
CERVISTA HUMAN PAPILLOMA VIRUS (HPV) 16/18 (P080015/S004)Hologic, Inc.2011-06-23
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S019)Hologic, Inc.2011-05-27
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S035)Hologic, Inc.2011-05-10
ADIANA PERMANMENT CONTRACEPTION SYSTEM (P070022/S018)Hologic, Inc.2011-05-10
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S008)Hologic, Inc.2011-05-05
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S016)Hologic, Inc.2011-04-14
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S017)Hologic, Inc.2011-04-08
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S034)Hologic, Inc.2011-04-08
CERVISTA HPV HR (P080014/S005)Hologic, Inc.2011-03-29
CERVISTA HPV 16/18 (P080015/S002)Hologic, Inc.2011-03-29
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S012)Hologic, Inc.2011-03-09
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