San Diego, CA, US · 26 510(k) clearances · 56 PMAs · 25 recalls (2 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | Class II | Radiology | 4 | 2025-07-31 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | Class II | Microbiology | 3 | 2024-11-15 |
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | Class II | Microbiology | 3 | 2022-06-03 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | Class II | Microbiology | 2 | 2025-09-25 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | Class II | Radiology | 1 | 2026-09-02 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology, Urology | 1 | 2026-08-12 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 1 | 2026-06-17 |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | Class II | Microbiology | 1 | 2025-02-13 |
| PAB | Cytomegalovirus (Cmv) Dna Quantitative Assay | Class II | Microbiology | 1 | 2025-01-17 |
| PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | Class II | Microbiology | 1 | 2024-11-25 |
| HIG | Insufflator, Hysteroscopic | Class II | Obstetrics/Gynecology | 1 | 2024-07-25 |
| MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | Class II | Microbiology | 1 | 2024-07-24 |
| QYV | Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm | Class II | Pathology | 1 | 2024-01-31 |
| LSL | Dna-Reagents, Neisseria | Class II | Microbiology | 1 | 2024-01-26 |
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | Class I | Microbiology | 1 | 2023-11-16 |
| OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | Class II | Immunology | 1 | 2023-11-06 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | Class II | Microbiology | 1 | 2023-05-05 |
| IZH | System, X-Ray, Mammographic | Class II | Radiology | 1 | 2020-10-05 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-08-26 | P920048-S030 | Rapid fFN for the TLiIQ System | 30-Day Notice | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2026-03-05 | P920048-S029 | Rapid fFN for the TLiIQ System | 30-Day Notice | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2026-03-05 | P920048-S028 | Rapid fFN for the TLiIQ System | 30-Day Notice | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2025-12-17 | P010013-S094 | NovaSure Model 10 RF Controller | 30-Day Notice | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2025-11-24 | P080003-S011 | Envision Mammography Platform | Normal 180 Day Track No User Fee | OTE | Digital Breast Tomosynthesis | Unknown |
| 2025-10-07 | P170025-S023 | Aptima HBV Quant Assay Kit, 100T; Aptima HBV Quant Calibrator Kit; Aptima HBV Quant Controls Kit; Aptima HBV Quant Targe | 30-Day Notice | MKT | Hepatitis Viral B Dna Detection | Microbiology |
| 2025-08-27 | P950039-S041 | ThinPrep Processor and ThinPrep Imaging System | 30-Day Notice | MKQ | Processor, Cervical Cytology Slide, Automated | Unknown |
| 2024-12-06 | P920048-S027 | Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System | 30-Day Notice | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2024-10-23 | P920048-S026 | TLiIQ QCette | 30-Day Notice | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2024-10-23 | P210029-S002 | Aptima CMV Quant Assay | 30-Day Notice | PAB | Cytomegalovirus (Cmv) Dna Quantitative Assay | Microbiology |
| 2024-10-23 | P170025-S022 | Aptima HBV Quant Assay | 30-Day Notice | MKT | Hepatitis Viral B Dna Detection | Microbiology |
| 2024-09-06 | P010013-S093 | NovaSure Impedance Controlled Endometrial Ablation System | 30-Day Notice | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2024-07-23 | P010013-S092 | NovaSure Impedance Controlled Endometrial Ablation System | 30-Day Notice | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2024-07-05 | P080003-S009 | Envision Mammography Platform | Normal 180 Day Track | OTE | Digital Breast Tomosynthesis | Unknown |
| 2024-06-17 | P170025-S019 | Aptima HBV Quant Assay | Normal 180 Day Track | MKT | Hepatitis Viral B Dna Detection | Microbiology |
| 2024-05-29 | P080003-S010 | Selenia Dimensions/3Dimensions | Normal 180 Day Track No User Fee | OTE | Digital Breast Tomosynthesis | Unknown |
| 2024-05-08 | P170025-S021 | Aptima HBV Quant Assay | 30-Day Notice | MKT | Hepatitis Viral B Dna Detection | Microbiology |
| 2023-12-21 | P920048-S025 | Rapid fFN for the TLiIQ System | 30-Day Notice | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2023-11-24 | P170025-S020 | Aptima HBV Quant Assay | 30-Day Notice | MKT | Hepatitis Viral B Dna Detection | Microbiology |
| 2023-10-27 | P010013-S091 | NovaSure Impedance Controlled Endometrial Ablation System | 30-Day Notice | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2023-09-22 | P010013-S090 | NovaSure Impedance Controlled Endometrial Ablation System | 30-Day Notice | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2023-08-24 | P920048-S024 | Rapid fFN for the TLilQ System | Special (Immediate Track) | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2022-12-01 | P010013-S089 | NovaSure Impedance Controlled Endometrial Ablation System | Special (Immediate Track) | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2022-11-02 | P010013-S088 | NovaSure Impedance Controlled Endometrial Ablation System | 30-Day Notice | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2022-08-04 | P010013-S087 | NovaSure Impedance Controlled Endometrial Ablation System | 30-Day Notice | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2022-07-20 | P210029-S001 | Aptima CMV Quant Assay | 30-Day Notice | PAB | Cytomegalovirus (Cmv) Dna Quantitative Assay | Microbiology |
| 2022-07-20 | P170025-S018 | Aptima HBV Quant Assay | 30-Day Notice | MKT | Hepatitis Viral B Dna Detection | Microbiology |
| 2022-05-09 | P920048-S023 | Rapid fFN for the TLiIQ System | 30-Day Notice | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2022-05-09 | P210029 | Aptima CMV Quant Assay | Original | PAB | Cytomegalovirus (Cmv) Dna Quantitative Assay | Microbiology |
| 2022-04-13 | P920048-S022 | Rapid fFN for the TLiIQ System | 30-Day Notice | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2022-02-28 | P920048-S021 | Rapid fFN for the TLiIQ System | 30-Day Notice | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2022-02-25 | P170025-S017 | Aptima HBV Quant Assay | Real-Time Process | MKT | Hepatitis Viral B Dna Detection | Microbiology |
| 2022-01-04 | P010013-S085 | NovaSure Impedance Controlled Endometrial Ablation System | Normal 180 Day Track No User Fee | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2021-12-09 | P010013-S082 | NovaSure Impedance Controlled Endometrial Ablation System | Normal 180 Day Track | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2021-11-15 | P010013-S086 | NovaSure Impedance Controlled Endometrial Ablation System | 30-Day Notice | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2021-08-30 | P010013-S084 | NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM | 30-Day Notice | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2021-06-30 | P010013-S081 | NovaSure Impedance Controlled Endometrial Ablation System | Normal 180 Day Track | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2021-05-21 | P920048-S019 | Rapid fFN for the TLiIQ System | Normal 180 Day Track No User Fee | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2021-05-14 | P950039-S040 | ThinPrep Genesis Processor | Normal 180 Day Track | MKQ | Processor, Cervical Cytology Slide, Automated | Unknown |
| 2021-04-29 | P920048-S020 | Rapid fFN for the TLilQ System | 30-Day Notice | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2021-03-30 | P010013-S083 | NovaSure Impedance Controlled Endometrial Ablation System | 30-Day Notice | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2020-11-06 | P920048-S015 | Rapid fFN for the TLiIQ System | 135 Review Track For 30-Day Notice | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2020-10-27 | P010013-S080 | NovaSure Impedance Controlled Endometrial Ablation System | 30-Day Notice | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2020-10-19 | P010013-S079 | NovaSure Impedance Controlled Endometrial Ablation System | 30-Day Notice | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2020-10-02 | P920048-S018 | Rapid fFN for the TLiIQ System | 30-Day Notice | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2020-09-03 | P920048-S016 | Rapid fFN for the TLiIQ System | Real-Time Process | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2020-08-12 | P950039-S039 | ThinPrep Processors and ThinPrep Imaging System | 135 Review Track For 30-Day Notice | MKQ | Processor, Cervical Cytology Slide, Automated | Unknown |
| 2020-08-12 | P920048-S017 | Rapid fFN for the TLiIQ System | 30-Day Notice | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2020-07-21 | P170025-S016 | Aptima HBV Quant Assay | 30-Day Notice | MKT | Hepatitis Viral B Dna Detection | Microbiology |
| 2020-07-21 | P160023-S019 | Aptima HCV Quant Dx Assay | 30-Day Notice | MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | Microbiology |
| 2020-03-02 | P010013-S075 | NovaSure Impedance Controlled Endometrial Ablation System | Real-Time Process | MNB | Device, Thermal Ablation, Endometrial | Unknown |
| 2020-02-14 | P170025-S015 | Aptima HBV Quant Assay | 30-Day Notice | MKT | Hepatitis Viral B Dna Detection | Microbiology |
| 2020-02-14 | P160023-S017 | Aptima HCV Quant Dx Assay | 30-Day Notice | MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | Microbiology |
| 2020-01-28 | P920048-S013 | Rapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay | Normal 180 Day Track | LKV | Enzyme Immunoassay, Fetal Fibronectin | Unknown |
| 2020-01-21 | P170025-S014 | Aptima HBV Quant Assay | Real-Time Process | MKT | Hepatitis Viral B Dna Detection | Microbiology |
| 2020-01-21 | P160023-S016 | Aptima HCV Quant Dx Assay | Real-Time Process | MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | Microbiology |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-04-08 | Class II | Ongoing | Z-2168-2026 | 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3D… | — | Complaints have been received of systems developing loose, missing, or broken internal bolts over time. |
| 2026-04-08 | Class II | Ongoing | Z-2167-2026 | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-60… | — | Complaints have been received of systems developing loose, missing, or broken internal bolts over time. |
| 2026-03-23 | Class II | Ongoing | Z-1949-2026 | Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: … | — | It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufactu… |
| 2026-02-18 | Class II | Ongoing | Z-1586-2026 | Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima … | — | Due to product exhibiting potential to generate either invalid or false negative results. |
| 2025-12-15 | Class II | Ongoing | Z-1314-2026 | Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. | — | Presence of particulates in affected devices that can be deposited into breast tissue during use. |
| 2025-12-12 | Class II | Ongoing | Z-1093-2026 | ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution. | — | Fungal contamination of affected lot with Parengyodontium album. |
| 2025-01-15 | Class II | Ongoing | Z-1170-2025 | Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Versi… | — | Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement. |
| 2025-01-08 | Class II | Ongoing | Z-1095-2025 | The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 7173… | — | Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or ove… |
| 2024-12-13 | Class II | Ongoing | Z-0907-2025 | Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD. | — | Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment. |
| 2024-11-08 | Class II | Ongoing | Z-0694-2025 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 | — | SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. |
| 2024-10-10 | Class I | Ongoing | Z-0328-2025 | BioZorb Marker. Radiographic soft tissue marker. | — | Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, an… |
| 2024-08-19 | Class II | Ongoing | Z-3248-2024 | Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 s… | — | Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of t… |
| 2024-06-13 | Class II | Ongoing | Z-2373-2024 | Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, … | — | Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essent… |
| 2024-03-13 | Class I | Ongoing | Z-1733-2024 | BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZ… | — | Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, o… |
| 2023-12-15 | Class II | Ongoing | Z-0782-2024 | PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully au… | — | Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. |
| 2023-09-14 | Class II | Ongoing | Z-1371-2024 | Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Re… | — | Use of assay along with plasma specimen may result in error code which would invalidate sample. |
| 2023-05-02 | Class II | Ongoing | Z-2035-2023 | Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the br… | — | The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery |
| 2023-01-16 | Class II | Ongoing | Z-1144-2023 | Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-… | — | C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual |
| 2022-10-10 | Class II | Completed | Z-0669-2025 | Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Nu… | — | IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set |
| 2022-08-09 | Class II | Ongoing | Z-1858-2022 | The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The Bi… | — | Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already … |
| 2022-03-18 | Class II | Ongoing | Z-0877-2022 | Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptoco… | — | Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results. |
| 2022-01-27 | Class II | Ongoing | Z-0750-2022 | Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fu… | — | Failed stability specifications for reagent kits that may result in false negative test results. |
| 2021-02-26 | Class II | Ongoing | Z-1369-2021 | Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to t… | — | There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results. |
| 2020-08-04 | Class II | Terminated | Z-2990-2020 | Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000 | — | Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility ex… |
| 2020-01-21 | Class II | Terminated | Z-1343-2020 | Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636, | — | The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of th… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-02 | K254090 | I-View® | MUE | Class II | Radiology |
| 2026-08-12 | K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | KNW | Class II | Gastroenterology, Urology |
| 2026-06-17 | K253634 | CoolSeal Generator® (CSL-200-90) | GEI | Class II | General, Plastic Surgery |
| 2025-09-25 | K251993 | Panther Fusion GI Expanded Bacterial Assay | PCH | Class II | Microbiology |
| 2025-09-25 | K251868 | Panther Fusion GI Bacterial Assay | PCH | Class II | Microbiology |
| 2025-07-31 | K243341 | Genius AI Detection 2.0 | QDQ | Class II | Radiology |
| 2025-02-13 | K243396 | Aptima SARS-CoV-2 Assay | QQX | Class II | Microbiology |
| 2025-01-17 | K243935 | Aptima CMV Quant Assay | PAB | Class II | Microbiology |
| 2024-11-25 | K243345 | Aptima BV Assay; Aptima CV/TV Assay | PQA | Class II | Microbiology |
| 2024-11-15 | K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | QOF | Class II | Microbiology |
| 2024-07-25 | K240886 | 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) | HIG | Class II | Obstetrics/Gynecology |
| 2024-07-24 | K233352 | Aptima HCV Quant Dx Assay | MZP | Class II | Microbiology |
| 2024-07-18 | K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | QOF | Class II | Microbiology |
| 2024-01-31 | DEN210035 | Genius Digital Diagnostics System with the Genius Cervical AI algorithm | QYV | Class II | Pathology |
| 2024-01-26 | K231329 | Aptima Neisseria gonorrhoeae Assay | LSL | Class II | Microbiology |
| 2023-11-16 | K230451 | Aptima® Chlamydia trachomatis Assay | MKZ | Class I | Microbiology |
| 2023-11-06 | K231316 | Aptima Trichomonas vaginalis Assay | OUY | Class II | Immunology |
| 2023-05-23 | K230096 | Genius AI Detection 2.0 with CC-MLO Correlation | QDQ | Class II | Radiology |
| 2023-05-16 | K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | QOF | Class II | Microbiology |
| 2023-05-05 | K231017 | Panther Fusion AdV/hMPV/RV Assay | OCC | Class II | Microbiology |
| 2022-10-06 | K221449 | Genius AI Detection 2.0 | QDQ | Class II | Radiology |
| 2022-06-03 | K220321 | 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) Tigris | QEP | Class II | Microbiology |
| 2020-11-18 | K201019 | Genius AI Detection | QDQ | Class II | Radiology |
| 2020-10-05 | K202294 | Affirm Contrast Biopsy | IZH | Class II | Radiology |
| 2020-05-17 | K200866 | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) | QEP | Class II | Microbiology |
| 2020-03-23 | K200436 | Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit | QEP | Class II | Microbiology |