HOLOGIC, INC.
817 devices
Multi-jurisdiction products
The same product registered across multiple national regulators, grouped so you can see its full clearance coverage at a glance.
- MyoSure Tissue Removal System Control Unit3 cert. types · 2 registered devices
- Fluent Pro Fluid Management System Procedure Kit3 cert. types · 2 registered devices
- CoolSeal™ Mini2 cert. types · 2 registered devices
- CoolSeal™ Reveal2 cert. types · 2 registered devices
- Trident HD Specimen Radiography System2 cert. types · 2 registered devices
- TruNode Single-Use Gamma Probe2 cert. types · 2 registered devices
- Faxitron Core Specimen Radiography System2 cert. types · 2 registered devices
- TRUNODE USER FEEDBACK UNIT2 cert. types · 2 registered devices
- Faxitron Wedge Surgical Specimen Container2 cert. types · 2 registered devices
Products
- Hologic Genius Digital Diagnostic SystemIn Vitro DiagnosticsHSA
- 고위험성감염체유전자검사시약In Vitro DiagnosticsMFDS
- CoolSeal Generator® (CSL-200-90)Surgical InstrumentsFDA 510(k)
- 고위험성감염체유전자검사시약In Vitro DiagnosticsMFDS
- AFFIRM PRONE BIOPSY SYSTEMOtherFDA 510(k)
- BREVERA BREAST BIOPSY NEEDLEOtherHealth Canada
- (BKV) PLASMID CONTROLOtherHealth Canada
- NEISSERIA GONORRHOEAE RESISTANCE PRIMERSOtherHealth Canada
- 세포및조직염색시약IOtherMFDS
- EXTRACTION REAGENTS -B, FUSION, IVDIn Vitro DiagnosticsHealth Canada
- APTIMA SARS-COV-2 ASSAYOtherFDA 510(k)Health Canada
- Panther Fusion GI Bacterial AssayOtherFDA 510(k)
- Panther Fusion GI Expanded Bacterial AssayOtherFDA 510(k)
- Genius AI Detection 2.0OtherFDA 510(k)
- Affirm®OtherFDA 510(k)
- COOLSEAL GENERATOROtherCE-MDRHealth Canada
- Sistema de mamografia digital e Sistema de tomossíntese digitalOtherANVISA
- 2등급 의료영상 검출·진단보조 소프트웨어Diagnostic ImagingMFDS
- APTIMA CMV QUANT ASSAYOtherFDA 510(k)Health Canada
- Sistema de Biópsia em Posição Prona AffirmOtherANVISA
- Aptima BV Assay; Aptima CV/TV AssayOtherFDA 510(k)
- 기타분자유전검사시약ⅠOtherMFDS
- Panther Fusion SARS-CoV-2/Flu A/B/RSV assayOtherFDA 510(k)
- FLUENT PRO PROCEDURE KITOtherFDA 510(k)Health Canada
- Fluent Pro Tissue TrapOtherFDA 510(k)
- Fluent Pro Waste BagOtherFDA 510(k)
- HOLOGIC RESPDIRECT COLLECTION KITOtherHealth Canada
- Fluent Pro Fluid Management SystemOtherFDA 510(k)CE-MDR
- Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)OtherFDA 510(k)
- APTIMA HCV QUANT DX ASSAYOtherFDA 510(k)Health Canada
- 핵산추출시약In Vitro DiagnosticsMFDS
- 검체 채취용 도구OtherMFDS
- Genius Digital Diagnostics System with the Genius Cervical AI algorithmOtherFDA 510(k)FDA De Novo
- Aptima Neisseria gonorrhoeae AssayOtherFDA 510(k)
- 생체 검사용 도구OtherMFDS
- GENIUS ACCESSORY KITOtherHealth Canada
- Fluent Fluid Management SystemOtherFDA 510(k)CE-MDR
- Aptima® Chlamydia trachomatis AssayOtherFDA 510(k)
- Aptima Trichomonas vaginalis AssayOtherFDA 510(k)
- Omni Instrument TrayOtherFDA 510(k)CE-MDR
- Panther Fusion®OtherFDA 510(k)
- Hologic Aptima® SARS-CoV-2 AssayIn Vitro DiagnosticsHSA
- 디지털 유방 촬영용 엑스선 장치Diagnostic ImagingMFDS
- FAXITRON WEDGEOtherFDA 510(k)
- Genius AI Detection 2.0 with CC-MLO CorrelationOtherFDA 510(k)
- Hologic Aptima Combo 2®OtherHSA
- PANTHER FUSION ADV/HMPV/RV ASSAYOtherFDA 510(k)Health Canada
- FAXITRON COREOtherFDA 510(k)
- FAXITRON MAMMOTOMEOtherFDA 510(k)
- 의료영상 분석 소프트웨어OtherMFDS
- 2등급 의료영상 전송장치 소프트웨어OtherMFDS
- Rapid fFNOtherFDA 510(k)
- APTIMA HPV 16 18/45 GENOTYPE ASSAYOtherHealth Canada
- APTIMA HPV ASSAYOtherHealth Canada
- 디지털 유방 촬영용 엑스선 장치Diagnostic ImagingMFDS
- NOVASURE ADVANCED IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION DISPOSABLE DEVICE KITOtherHealth Canada
- Sizer SetOtherFDA 510(k)
- Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) TigrisOtherFDA 510(k)
- AQUILEX FLUID CONTROL SYSTEMOtherHealth Canada
- Hologic Aptima® HPV 16 18/45 Genotype AssayOtherHSA
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