Home › Device types › KNW
Instrument, Biopsy
FDA product code KNW · Class 2 · Gastroenterology, Urology
4,716
Registered devices
23,838
Adverse events
106
Recalls
364
510(k) clearances
Devices with this code
COX — MEDAX SRL UNIPERSONALEChiba Biopsy Needle with Echogenic Tip — ARGON MEDICAL DEVICES, INC.CorVocet™ — Merit Medical Systems, Inc.Mammotome MR — DEVICOR MEDICAL PRODUCTS, INC.EleVation™ — Bard Peripheral Vascular, Inc.Remington Medical, Inc. Automatic Cutting Needle (NAC) — REMINGTON MEDICAL, INC.Mammotome elite — DEVICOR MEDICAL PRODUCTS, INC.MEDONE ULTRA — MEDAX SRL UNIPERSONALECOX — MEDAX SRL UNIPERSONALEVelox Pro — MEDAX SRL UNIPERSONALEMIELO-CAN ILIAC — STERYLAB SRLPro-Mag™ Biopsy Needle — ARGON MEDICAL DEVICES, INC.Disposable needle for reusable biopsy gun — Möller Medical GmbHTemno — CAREFUSION 2200, INCRemington Medical, Inc. Automatic Cutting Needle (NAC) — REMINGTON MEDICAL, INC.RANR-1115N5T — RANFAC CORP.TEMNO Elite™ — Merit Medical Systems, Inc.Invivo — Philips Ds North America LLCSureAim Coaxial Biopsy Needle — Canyon Medical Inc.SuperCore™ Biopsy Instrument — ARGON MEDICAL DEVICES, INC.Brevera Breast Biopsy System — Hologic, Inc.MC-RAN-BZL-8C — RANFAC CORP.MONOPTY — Bard Peripheral Vascular, Inc.Automatic Cutting Needle — REMINGTON MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-01 | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| 2026-06-01 | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| 2026-06-01 | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| 2025-12-15 | Hologic, Inc | Presence of particulates in affected devices that can be deposited into breast tissue during use. |
| 2025-01-15 | Hologic, Inc | Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement. |
| 2024-09-30 | Bard Peripheral Vascular Inc | Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the |
| 2024-07-02 | Argon Medical Devices, Inc | Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of |
| 2023-11-08 | Bard Peripheral Vascular Inc | The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed |
| 2023-08-10 | Bard Peripheral Vascular Inc | Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohib |
| 2023-05-02 | Hologic, Inc | The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery |
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