Devicor Medical Products, Inc.
Devicor Medical Products, Inc. holds FDA 510(k) medical device clearances, first cleared 2012, most recent 2026, with 5 FDA device recalls on record.
Top product codes for Devicor Medical Products, Inc.
FDA recalls by Devicor Medical Products, Inc.
- Z-2239-2026 — HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
- Z-1124-2022 — HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
- Z-0070-2021 — Neoprobe GDS Control Unit, Model Number NPCU3
- Z-1512-2017 — Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
- Z-2211-2016 — Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile. Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Devicor Medical Products, Inc.
- K260365 — Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module +5 more
- K253761 — HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)
- K243095 — Mammotome AutoCore Single Insertion Core Biopsy System
- K240527 — HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
- K232615 — LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)) +2 more
- K221961 — HydroMARK Plus Breast Biopsy Site Marker
- K212158 — HydroMARK Breast Biopsy Site Marker
- K210752 — HydroMARK Breast Biopsy Site Marker
- K203097 — HydroMARK Breast Biopsy Site Markers
- K202012 — Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
- K170803 — HydroMARK Breast Biopsy Site Markers
- K153709 — Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet
- K161021 — HydroMARK Breast Biopsy Site Marker
- K152989 — Mammotome revolve Dual Vacuum Assist Biopsy System
- K123259 — MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM
- K112411 — MAMMOTOME ELITE BIOPSY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.