Hologic, Inc.
171 devices · 2,699 adverse event reports · 14 deaths reported · 41 devices named in recalls
Counts reflect reports that name each device's exact identifier. Larger companies sell more devices, so totals should not be read as a safety ranking.
- TriMark TRIMARK-EVIVA-2S-13MARKER, RADIOGRAPHIC, IMPLANTABLE4 reports
- SecurMark SMARK-EVIVA-2S-13MARKER, RADIOGRAPHIC, IMPLANTABLE4 reports
- Brevera Breast Biopsy System BREV09INSTRUMENT, BIOPSY4 reports
- Aptima® KIT, BOX 1, REFRIGERATED, ACV/TV, 100T, IVDVaginitis and bacterial vaginosis nucleic acid detection system4 reports
- APTIMA AC2, ROOM TEMP, 250T, READY MADENucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections4 reports
- Rapid fFN® KIT, RAPID FFN 26 CASSETTE TLIIQ SYSTEMENZYME IMMUNOASSAY, FETAL FIBRONECTIN4 reports
- Aptima® APTIMA SWAB SPECIMEN COLLECTION KITInstrumentation for clinical multiplex test systems4 reports
- MYOSURE HYSTEROSCOPY SET 40-250HYSTEROSCOPE (AND ACCESSORIES)4 reports
- NovaSure NovaSure ControllerDEVICE, THERMAL ABLATION, ENDOMETRIAL3 reports
- EVIVA_0910-12TINSTRUMENT, BIOPSY3 reports
- Aptima Combo 2® KIT,APTIMACOMBO2,100T,REF,CEIVD-UPDATEDDNA-REAGENTS, NEISSERIA3 reports
- Acessa ProVu System 7700COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)3 reports
- Acessa ProVu System 7100COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)3 reports
- TriMark TRIMARK TD 13MRMARKER, RADIOGRAPHIC, IMPLANTABLE2 reports
- TriMark TRIMARKTD-2S-36-09MARKER, RADIOGRAPHIC, IMPLANTABLE2 reports
- CELEROMARKMARKER, RADIOGRAPHIC, IMPLANTABLE2 reports
- SecurMark SMARK-CELERO-2SMARKER, RADIOGRAPHIC, IMPLANTABLE2 reports
- SecurMark MRI SMARK-M-SS2MARKER, RADIOGRAPHIC, IMPLANTABLE2 reports
- Sertera Biopsy Device Sertera-12INSTRUMENT, BIOPSY2 reports
- ATEC Sapphire 200INSTRUMENT, BIOPSY2 reports
- ATEC 0909-20INSTRUMENT, BIOPSY2 reports
- ATEC 0912-12INSTRUMENT, BIOPSY2 reports
- Aptima Combo 2® KIT, BX 1 (REFRIG) AC2, 100T, AS, IVDDNA-REAGENTS, NEISSERIA2 reports
- Multicare Platinum 8-004-0017System, x-ray, mammographic2 reports
- Panther Fusion® AMR KIT, PANTHER FUSION, 96T, IVDRespiratory virus panel nucleic acid assay system2 reports
- Aptima® APTIMA VAGINAL SWAB COLLECTION KITDNA-REAGENTS, NEISSERIA2 reports
- TriMark TRIMARK TD 1309MARKER, RADIOGRAPHIC, IMPLANTABLE1 report
- TriMark TRIMARKTD-2S-13-09MARKER, RADIOGRAPHIC, IMPLANTABLE1 report
- TriMark TRIMARKTD-2S-13-12MARKER, RADIOGRAPHIC, IMPLANTABLE1 report
- TriMark TRIMARKTD-2S-13-MRMARKER, RADIOGRAPHIC, IMPLANTABLE1 report
- CELEROMARK CELEROMARK-2SMARKER, RADIOGRAPHIC, IMPLANTABLE1 report
- SecurMark SMARK-CELEROMARKER, RADIOGRAPHIC, IMPLANTABLE1 report
- SecurMark for ATEC SMARK-ATEC-13-12MARKER, RADIOGRAPHIC, IMPLANTABLE1 report
- TriMark TRIMARK-EVIVA-13MARKER, RADIOGRAPHIC, IMPLANTABLE1 report
- SecurMark SMARK-E13-SS3MARKER, RADIOGRAPHIC, IMPLANTABLE1 report
- SecurMark MRI SMARK-M-SS3MARKER, RADIOGRAPHIC, IMPLANTABLE1 report
- ImageChecker CAD 10.0Analyzer,medical image1 report
- Aptima® KIT, APTIMA HPV 16 18/45, 100 REF IVDKit, rna detection, human papillomavirus1 report
- ThinPrep Imaging System ThinPrep Imaging System Imaging StationREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED1 report
- ATEC ATEC CanisterINSTRUMENT, BIOPSY1 report
- ThinPrep 5000 ProcessorProcessor, cervical cytology slide, automated1 report
- MULTIVIEWSystem, image processing, radiological1 report
- MyoSure Tissue Removal Device 10-401HYSTEROSCOPE (AND ACCESSORIES)1 report
- ATEC 0914-12MRINSTRUMENT, BIOPSY1 report
- EVIVA_0910-20INSTRUMENT, BIOPSY1 report
- MyoSure Tissue Removal System Control Unit 10-500HYSTEROSCOPE (AND ACCESSORIES)1 report
- MyoSure Tissue Removal System Control Unit 10-550HYSTEROSCOPE (AND ACCESSORIES)1 report
- Aptima® KIT, ATV-V2, REFRIGERATED, 100TTrichomonas vaginalis nucleic acid amplification test system1 report
- Flourocsan InSight InSight FDImage-intensified fluoroscopic x-ray system, mobile1 report
- InSight 2System, x-ray, fluoroscopic, image-intensified1 report
- ACCUPROBE® KIT,ACCUPROBE,M. TUBERCULOSISDNA-REAGENTS, MYCOBACTERIUM SPP.1 report
- Affirm Prone Biopsy System PBX-SYS-AFFIRM-2DSystem, x-ray, mammographic1 report
- INVADER INVADER FACTOR II, 144 TESTSTEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR1 report
- INVADER INVADER FACTOR V, 144 TESTSTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR1 report
- ATEC EMERALDINSTRUMENT, BIOPSY1 report
- Flourocsan InSight InSight FD RefreshImage-intensified fluoroscopic x-ray system, mobile1 report
- MyoSure Rod Lens Hysteroscope Outflow Channel 40-201HYSTEROSCOPE (AND ACCESSORIES)1 report
- 3.7mm Diagnostic Sheath 60-201HYSTEROSCOPE (AND ACCESSORIES)1 report
- 5.5mm Operative Sheath 60-202HYSTEROSCOPE (AND ACCESSORIES)1 report
- Aptima® KIT, BOX 1, REFRIGERATED, ABV, 100T, IVDAssayed external control material for microbiology nucleic acid amplification (NAT) assays1 report
- DEFINITY CERVICAL DILATOR, 7MM DCD-701Catheter, balloon, dilation of cervical canal1 report
- 30 Degree Omni Hysteroscope 60-200-30HYSTEROSCOPE (AND ACCESSORIES)1 report
- ThinPrep 5000 Processor TP-5000 Autoloader Accessory KitProcessor, cervical cytology slide, automated1 report
- APTIMA AC2, REFRIG, 250T, READY MADEDNA-REAGENTS, NEISSERIA1 report
- APTIMA PANTHER,TRICH REFRIG,V2,250T,READY MADETrichomonas vaginalis nucleic acid amplification test system1 report
- Acessa ProVu System 3000COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)1 report
- Acessa ProVu System 5200COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)1 report
- OMNI OMNI-G-001Hysteroscope accessories1 report
- MyoSure Tissue Removal Device 40-902HYSTEROSCOPE (AND ACCESSORIES)1 report
- Aptima® APTIMA URINE SPECIMEN COLLECTION KITInstrumentation for clinical multiplex test systems1 report
- MYOSURE XL HYSTEROSCOPY SET 50-250XLHYSTEROSCOPE (AND ACCESSORIES)1 report