ApprovalTrail

Company · Sunnyvale, CA, United States

Hologic, Inc.

Everything this company holds in Health Canada’s product databases, as the company’s name is spelled there.

Drug products (DIN)
0
0 authorized now
Natural health products
0
0 active licences
Medical device licences
169
82 active
Notices of Compliance
0

Medical device licences

Active licences first, newest first.

NameLicenceStatus
NG RESISTANCE PRIMERS AND PROBE ANALYTE SPECIFIC REAGENTS (ASR) OLIGONUCLEOTIDES114854Issued (active) · Class 2
PANTHER FUSION GI EXPANDED BACTERIAL ASSAY114437Issued (active) · Class 3
PANTHER FUSION GI BACTERIAL ASSAY114394Issued (active) · Class 3
APTIMA SARS-COV-2 ASSAY114038Issued with conditions · Class 2
COOLSEAL VESSEL SEALING SYSTEM113597Issued (active) · Class 3
RESPDIRECT COLLECTION KIT111815Issued (active) · Class 2
FLUENT PRO FLUID MANAGEMENT SYSTEM111265Issued (active) · Class 2
GENIUS DIGITAL DIAGNOSTICS SYSTEM110615Issued (active) · Class 3
APTIMA CMV QUANT ASSAY108241Issued (active) · Class 3
AQUILEX FLUID CONTROL SYSTEM107759Issued (active) · Class 2
GENIUS AI DETECTION107454Issued with conditions · Class 3
THINPREP GENESIS PROCESSOR107413Issued (active) · Class 3
ACESSA PROVU SYSTEM106456Issued (active) · Class 3
CORONAVIRUS PRIMERS AND PROBES ANALYTE SPECIFIC REAGENTS (ASR) OLIGONUCLEOTIDES104475Issued (active) · Class 2
APTIMA CV/TV ASSAY104221Issued (active) · Class 3
UNIFI WORKSPACE104116Issued (active) · Class 2
MYOSURE SINGLE USE SEAL SET104061Issued (active) · Class 2
APTIMA BV ASSAY103797Issued (active) · Class 2
OMNI LOK CERVICAL SEAL103726Issued (active) · Class 2
FLUENT FLUID MANAGEMENT SYSTEM103464Issued (active) · Class 2
PANTHER FUSION MRSA ASSAY103397Issued (active) · Class 3
APTIMA MYCOPLASMA GENITALIUM ASSAY102819Issued (active) · Class 3
GROUP A STREPTOCOCCUS (GAS) PRIMERS AND PROBE ANALYTE SPECIFIC REAGENT (ASR) OLIGONUCLEOTIDES102732Issued (active) · Class 2
PANTHER FUSION GBS ASSAY102240Issued (active) · Class 3
OMNI HYSTEROSCOPE102256Issued (active) · Class 2
DNA CYTOMEGALOVIRUS (CMV) PRIMERS AND CMV PROBE ANALYTE SPECIFIC REAGENT OLIGONUCLEOTIDES102224Issued (active) · Class 2
DNA BK VIRUS (BKV) PRIMERS AND PROBE ANALYTE SPECIFIC REAGENT OLIGONUCLEOTIDES102153Issued (active) · Class 2
DNA EPSTEIN-BARR VIRUS (EBV) PRIMERS AND PROBE ANALYTE SPECIFIC REAGENT (ASR) OLIGONUCLEOTIDES102154Issued (active) · Class 2
DNA AND RNA IC PRIMERS AND PROBES ANALYTE SPECIFIC REAGENT (ASR) OLIGONUCLEOTIDES102155Issued (active) · Class 2
DNA VARICELLA ZOSTER VIRUS (VZV) PRIMERS AND PROBE ANALYTE SPECIFIC REAGENT (ASR) OLIGONUCLEOTIDES102156Issued (active) · Class 2
IN-VITRO TRANSCRIPT (IVT) CONTROLS102109Issued (active) · Class 2
APTIMA HERPES SIMPLEX VIRUSES 1 & 2 ASSAY101992Issued (active) · Class 3
3DIMENSIONS MAMMOGRAPHY SYSTEM101870Issued (active) · Class 3
VIERA PORTABLE BREAST ULTRASOUND LINEAR SCANNER100971Issued (active) · Class 3
MYOSURE MANUAL TISSUE REMOVAL DEVICE100514Issued (active) · Class 2
BREVERA BREAST BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY100291Issued (active) · Class 2
FLU A/B/RSV ASSAY (PANTHER FUSION SYSTEM)100153Issued (active) · Class 2
PANTHER FUSION PARAFLU ASSAY100154Issued (active) · Class 2
PANTHER FUSION ADV/HMPV/RV ASSAY100152Issued (active) · Class 2
TRUNODE SURGICAL GAMMA PROBE99405Issued (active) · Class 2
AFFIRM PRONE BIOPSY SYSTEM99217Issued (active) · Class 3
APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT99064Issued (active) · Class 2
PROCLEIX PANTHER SYSTEM97959Issued (active) · Class 4
APTIMA HBV QUANT ASSAY97745Issued (active) · Class 3
APTIMA HCV QUANT DX ASSAY97688Issued (active) · Class 4
THINPREP 5000 PROCESSOR96649Issued (active) · Class 3
FAXITRON PATH DIGITAL SPECIMEN RADIOGRAPHY SYSTEM96502Issued (active) · Class 2
FAXITRON CORE SPECIMEN RADIOGRAPHY SYSTEM96456Issued (active) · Class 2
THINPREP 2000 PROCESSOR96405Issued (active) · Class 3
APTIMA HIV-1 QUANT DX ASSAY96184Issued (active) · Class 4
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM95084Issued (active) · Class 2
HORIZON93497Issued (active) · Class 3
APTIMA TRICHOMONAS VAGINALIS ASSAY91094Issued (active) · Class 3
APTIMA HPV ASSAY KIT90633Issued (active) · Class 3
APTIMA HPV 16 18/45 GENOTYPE ASSAY90634Issued (active) · Class 3
APTIMA CERVICAL SPECIMEN COLLECTION AND TRANSPORT KIT89489Issued (active) · Class 2
MYOSURE TISSUE REMOVAL SYSTEM88689Issued (active) · Class 2
MYOSURE HYSTEROSCOPY SYSTEM88694Issued (active) · Class 2
SECURMARK BIOPSY SITE MARKERS87409Issued (active) · Class 3
PANTHER SYSTEM86931Issued (active) · Class 4
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM86523Issued (active) · Class 3
EVIVA BREAST BIOPSY SYSTEM85461Issued (active) · Class 2
ATEC BREAST BIOPSY AND EXCISION SYSTEM - CONSOLE85462Issued (active) · Class 2
CELERO BIOPSY DEVICE81922Issued (active) · Class 2
SPECIMEN COLLECTION KIT FOR THE FETAL FIBRONECTIN (FFN) TEST81015Issued (active) · Class 2
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM79158Issued (active) · Class 3
R2 CENOVA (CENOVA)78741Issued (active) · Class 2
QUANTRA (R2 QUANTRA)78742Issued (active) · Class 2
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE76012Issued (active) · Class 3
APTIMA UNISEX SWAB SPECIMEN COLLECTION KIT FOR ENDOCERVICAL AND URETHRAL SWAB SPECIMENS74226Issued (active) · Class 2
BIOPSY SITE MARKERS71081Issued (active) · Class 3
FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM71072Issued (active) · Class 3
ATEC BREAST BIOPSY & EXCISION SYSTEM (PEARL)70899Issued (active) · Class 2
SECURVIEW DX PACS WORKSTATION70782Issued (active) · Class 2
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS70729Issued (active) · Class 3
ATEC BREAST BIOPSY & EXCISION SYSTEM68677Issued (active) · Class 2
THINPREP IMAGING SYSTEM67049Issued (active) · Class 2
IMAGE CHECKER64681Issued (active) · Class 2
DISCOVERY QDR SERIES BONE DENSITOMETER SYSTEM62783Issued (active) · Class 3
APTIMA COMBO 2 ASSAY61047Issued (active) · Class 3
RAPID FFN FOR THE TLIIQ SYSTEM14240Issued (active) · Class 3
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM13678Issued (active) · Class 3
MYCOPLASMA GENITALIUM ANALYTE SPECIFIC REAGENT OLIGONUCLEOTIDES99330Discontinued at renewal · Class 2
ANALYTE SPECIFIC REAGENTS99323Discontinued at renewal · Class 2
PRIMA94126Discontinued at renewal · Class 2
SURESOUND UTERINE SOUND93247Discontinued at renewal · Class 2
AQUILEX FLUID CONTROL SYSTEM92799Suspended · Class 2
PRODESSE PROGASTRO SSCS ASSAY91935Discontinued at renewal · Class 3
GEN-PROBE GROUP A STREPTOCOCCUS DIRECT TEST90386Discontinued at renewal · Class 3
BACS (BREAST ARTERIAL CALCIFICATION SCORING)88756Discontinued at renewal · Class 2
PROGENSA PCA3 ASSAY KIT86877Discontinued at renewal · Class 3
PROFAST+ ASSAY85425Discontinued at renewal · Class 3
PRODESSE PROADENO+85142Discontinued at renewal · Class 2
GEN-PROBE DTS SYSTEMS82037Discontinued at renewal · Class 3
R2 DIGITALNOW HD SOFTWARE APPLICATION80682Discontinued at renewal · Class 2
ADIANA PERMANENT CONTRACEPTION SYSTEM80305Discontinued at renewal · Class 3
CERVISTA HPV HR78882Discontinued at renewal · Class 3
PROPARAFLU+ ASSAY78025Discontinued at renewal · Class 2
MAMMOSITE CAVITY EVALUATION DEVICE77747Cancelled · Class 2
PROGASTRO CD ASSAY (CLOSTRIDIUM)77382Discontinued at renewal · Class 3
PRO HMPV+ ASSAY77383Discontinued at renewal · Class 2
SENTINELLE PROSTATE SOFTWARE76151Discontinued at renewal · Class 2
DIGITAL STEREOLOCK II75977Discontinued at renewal · Class 3
PROFLU+75357Discontinued at renewal · Class 2
APTIMA SPECIMEN TRANSFER KIT74075Cancelled · Class 2
PROCLEIX TIGRIS SYSTEM73973Discontinued at renewal · Class 4
PROCLEIX SYSTEM73974Discontinued at renewal · Class 4
GEN-PROBE PSA PROBE73668Discontinued at renewal · Class 2
GEN-PROBE PCA3 PROBE73653Discontinued at renewal · Class 2
APTIMA TRICHOMONAS VAGINALIS ANALYTE SPECIFIC REAGENT OLIGONUCLEOTIDES72460Discontinued at renewal · Class 2
SENTINELLE BREAST SOFTWARE SYSTEM71033Discontinued at renewal · Class 2
ATEC BREAST BIOPSY & EXCISION SYSTEM (EMERALD)70898Discontinued at renewal · Class 2
EXPLORER QDR SERIES X-RAY BONE DENSITOMETER64782Discontinued at renewal · Class 3
IMAGE CHECKER DISPLAY UNITS64682Discontinued at renewal · Class 2
GEN-PROBE APTIMA VAGINAL SWAB SPECIMEN COLLECTION KIT64712Discontinued at renewal · Class 2
TIGRIS DTS ANALYZER SYSTEM63723Discontinued at renewal · Class 3
RAPID ID62981Discontinued at renewal · Class 2
MULTICARE PLATINUM MAMMOGRAPHY SYSTEM62841Discontinued at renewal · Class 3
GEN-PROBE PACE SPECIMEN COLLECTION SPECIMEN COLLECTION KIT - URETHRAL/CONJUNCTIVE61830Discontinued at renewal · Class 2
SELENIA MAMMOGRAPHY SYSTEM60368Discontinued at renewal · Class 3
DR1000C SYSTEM60005Discontinued at renewal · Class 3
RADEX SYSTEM39212Discontinued at renewal · Class 3
EPEX SYSTEM38895Discontinued at renewal · Class 3
GLIASITE RADIATION THERAPY SYSTEM (RTS)38949Discontinued at renewal · Class 4
AFFINITY MAMMOGRAPHY SYSTEM37093Discontinued at renewal · Class 3
QDR 4500 BONE DENSITOMETER36571Discontinued at renewal · Class 3
DELPHI BONE DENSITOMETER36534Discontinued at renewal · Class 3
AFFINITY PADDLES36208Discontinued at renewal · Class 2
QDR 4000 BONE DENSITOMETER36088Discontinued at renewal · Class 3
MAMMOSITE RADIATION THERAPY (RTS) HDR AFTERLOADER ACCESSORIES TRAY31276Discontinued at renewal · Class 3
MAMMOSITE RADIATION THERAPY SYSTEM APPLICATOR TRAY31201Cancelled · Class 3
SAHARA CLINICAL BONE SONOMETER28433Discontinued at renewal · Class 2
METEOR MOBILE RADIOGRAPHIC SYSTEM18678Discontinued at renewal · Class 2
MOBILE MINI C-ARM FLUOROSCOPIC X-RAY SYSTEM15421Discontinued at renewal · Class 3
UNICATH SP15137Discontinued at renewal · Class 3
FETAL FIBRONECTIN ENZYME IMMUNOASSAY14241Cancelled · Class 3
DIGITAL SPOT MAMMOGRAPHY (DSM)12073Discontinued at renewal · Class 3
M-IIE MAMMOGRAPHY SYSTEM12075Discontinued at renewal · Class 3
M-III MAMMOGRAPHY SYSTEM12083Discontinued at renewal · Class 3
MULTICARE MAMMOGRAPHY SYSTEM12084Discontinued at renewal · Class 3
M-IV MAMMOGRAPHY SYSTEM12087Discontinued at renewal · Class 3
RT-125 MOBILE X-RAY UNIT12090Discontinued at renewal · Class 2
T-350 MAMMOGRAPHY SYSTEM12094Discontinued at renewal · Class 3
MAMMOGRAPHY SYSTEMS10478Discontinued at renewal · Class 2
BT-300/BT-300L TOMOGRAPHY SYSTEM10480Discontinued at renewal · Class 2
COMPU-MASS RADIOGRAPHIC GENERATOR CM-42510504Discontinued at renewal · Class 2
IMAGER RADIOGRAPHIC GENERATOR10507Discontinued at renewal · Class 2
HIGH FREQUENCY X-RAY GENERATORS 100 & 1000 SERIES10508Discontinued at renewal · Class 2
GEN-PROBE PACE SPECIMEN COLLECTION SPECIMEN COLLECTION KIT-ENDCERVICAL10526Discontinued at renewal · Class 2
GEN-PROBE PACE 2 SYSTEM FOR NEISSERIA GONORRHOEAE10103Discontinued at renewal · Class 3
GEN-PROBE PACE 2 NEISSERIA GONORRHOEAE PROBE COMPETITION ASSAY (PCA)10104Discontinued at renewal · Class 3
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY10105Discontinued at renewal · Class 3
GEN-PROBE GROUP A STREPTOCOCCUS DIRECT TEST10112Discontinued at renewal · Class 3
GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST10116Discontinued at renewal · Class 3
GEN-PROBE PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS10117Discontinued at renewal · Class 3
GEN-PROBE PACE 2C SYSTEM FOR CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE10118Discontinued at renewal · Class 3
GEN-PROBE PACE 2 CHLAMYDIA TRACHOMATIS PROBE COMPETITION ASSAY (PCA)10119Discontinued at renewal · Class 3
STEREOLOC8733Discontinued at renewal · Class 2
COLLIMATOR MANUAL AND AUTOMATIC7766Discontinued at renewal · Class 2
DIGITAL SPOT IMAGER7629Discontinued at renewal · Class 2
RADIOGRAPHIC TABLE (NON-TILTING, POWERED)7631Discontinued at renewal · Class 2
TUBE MONT X-RAY DIAGNOSTIC7636Discontinued at renewal · Class 2
UPRIGHT BUCKY STRUCTURE7638Discontinued at renewal · Class 2
GEN-PROBE ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE IDENTIFICATION TEST7476Discontinued at renewal · Class 2
GEN-PROBE ACCUPROBE LISTERIA MONOCYTOGENES CULTURE IDENTIFICATION TEST7514Discontinued at renewal · Class 2
GEN-PROBE ACCUPROBE CAMPYLOBACTER CULTURE IDENTIFICATION KIT7517Discontinued at renewal · Class 2
GEN-PROBE ACCUPROBE BLASTOMYCES DERMATITIDIS CULTURE IDENTIFICATION TEST7520Discontinued at renewal · Class 2
STEROLOC II6633Discontinued at renewal · Class 3
PMT-660051Discontinued at renewal · Class 2

Recalls and safety alerts that mention its products

Health Canada’s recall notices do not carry licence numbers, so these are matched by name. A notice may cover another product or only some lots: read it to see what it covers.