| Marrow Marxman (K260572) | Medimetrix, LLC | 2026-08-04 |
| Promisemed VeriEcto Automatic Biopsy Needles (K261196) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-12 |
| Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char (K260365) | Devicor Medical Products, Inc. | 2026-03-04 |
| ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial (K252795) | Argon Medical Devices, Inc. | 2026-02-23 |
| EnCor EnCompass™ Breast Biopsy and Tissue Removal System (K252681) | Bard Peripheral Vascular, Inc. | 2025-12-12 |
| Resitu Slider 09 (RESL09) (K252183) | Resitu Medical AB | 2025-09-24 |
| Forcyte Autograft Harvest Kit (K243407) | Forcyte Medical, LLC | 2025-07-29 |
| Disposable Biopsy Needle (K244018) | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-07-22 |
| Disposable Biopsy Needle (K243296) | Carbon (Shenzhen) Medical Device Co., Ltd. | 2025-07-11 |
| Marquee™ Disposable Core Biopsy Instrument and Instrument Kit (K250032) | Bard Peripheral Vascular, Inc. | 2025-07-10 |
| ExpressCore Biopsy Device (K243886) | Inrad, Inc. | 2025-04-29 |
| ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (K243945) | SurGenTec, LLC | 2025-04-24 |
| Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) (K242128) | Xaga Surgical | 2025-02-27 |
| Bone Marrow Biopsy Needle (K242322) | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 |
| Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle (K241793) | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 |
| Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) (K242228) | Triopsy Medical, Inc. | 2025-01-10 |
| Mammotome AutoCore™ Single Insertion Core Biopsy System (K243095) | Devicor Medical Products, Inc. | 2024-10-29 |
| TRAP EASY (K242029) | H.S Hospital Service S.P.A | 2024-10-09 |
| ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (K240664) | SurGenTec, LLC | 2024-08-09 |
| Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM (K233294) | Itp Innovative Tomography Products GmbH | 2024-06-18 |
| M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle (K233031) | Canyon Medical, Inc. | 2024-01-17 |
| SUREcore Prime Biopsy Instrument (K230646) | Uro-1 Medical, Inc. | 2023-11-29 |
| EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT) (K233220) | Senorx, Inc. | 2023-10-27 |
| OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver (K230015) | Laurane Medical Sas | 2023-06-16 |
| Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument (K223300) | Geotek Medikal Ltd Sti | 2023-04-21 |
| M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle (K222865) | Canyon Medical, Inc. | 2023-04-03 |
| Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) (K223612) | Ranfac Corporation | 2023-02-21 |
| Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10) (K222462) | Itp Innovative Tomography Products GmbH | 2023-01-20 |
| SUREcore Plus Biopsy Instrument (K220611) | Uro-1, Inc. | 2022-12-02 |
| NeoNavia Biopsy System (K220595) | Neodynamics AB | 2022-09-08 |
| Disposable Semi Automatic Biopsy Instrument (K212820) | Suzhou Leapmed Healthcare Corporation | 2022-07-06 |
| NovaCore Semi-Automatic Biopsy Instrument (K213232) | Argon Medical Devices | 2022-07-01 |
| Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle (K214063) | Guangzhou Shengwei Medical Devices Co., Ltd. | 2022-06-03 |
| Promisemed Fine Biopsy Needle (K213683) | Promisemed Hangzhou Meditech Co., Ltd. | 2022-04-22 |
| BD Trek Powered Bone Biopsy System (K213896) | Bard Peripheral Vascular | 2022-03-30 |
| TeesuVac Breast Biopsy Device Mark 1 (K212079) | Teesuvac Aps | 2022-02-02 |
| Arthrex Vortex Threaded Bone Marrow Recovery Needle (K213213) | Arthrex, Inc. | 2021-11-19 |
| Disposable Automatic Core Biopsy Instrument (K212284) | Suzhou Leapmed Healthcare Corporation | 2021-11-10 |
| Uramix CuraWay Biopsy Needle (K203141) | Uramix, Inc. | 2021-09-17 |
| Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles (K210946) | Promisemed Hangzhou Meditech Co., Ltd. | 2021-08-12 |
| EleVation Breast Biopsy System (K211933) | Bard Peripheral Vascular | 2021-07-15 |
| EnCor Breast Biopsy Probe with Rinse Tube (K210654) | Senorx, Inc. | 2021-03-31 |
| Avitus(r) Bone Harvester (K210631) | Avitus Orthopaedics, Inc. | 2021-03-31 |
| VMCore Biopsy Needle (K201650) | Uro-1, Inc. | 2021-01-15 |
| Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm (K203397) | Biopsybell S.R.L. | 2021-01-11 |
| Ran-Flex-B Bone Marrow Aspiration Needle (K202287) | Ranfac Corporation | 2020-09-18 |
| Temno Elite Biopsy System (K201166) | Merit Medical Systems, Inc. | 2020-08-28 |
| Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System (K202012) | Devicor Medical Products, Inc. | 2020-08-18 |
| Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices (K201244) | Transmed7, LLC | 2020-08-07 |
| Medone Ultra, Medextra (K192101) | Medax Srl Unipersonale | 2020-04-02 |
| MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System (K192099) | Medax Srl Unipersonale | 2020-04-02 |
| CytoCore (K200278) | Praxis Medical, LLC | 2020-03-31 |
| APrioCore Plus (K193268) | Apriomed AB | 2020-02-27 |
| EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G (K192948) | Bard Peripheral Vascular, Inc. | 2019-11-07 |
| Remington Medical, Inc. Automatic Cutting Needle (NAC) (K191315) | Remington Medical, Inc. | 2019-07-12 |
| J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, (K190177) | Ranfac Corporation | 2019-06-12 |
| Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix (K190378) | Bioncise NV | 2019-05-24 |
| Ranfac Cartilage Biopsy Needle (K183146) | Ranfac Corporation | 2019-04-25 |
| Medax Biopsy Systems III (K181803) | Medax Srl Unipersonale | 2018-10-18 |
| BEXCORE Breast Biopsy System, Biopsy Needle (K171890) | Medical Park Co., Ltd. | 2018-08-20 |
| SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device (K173316) | Transmed7, LLC | 2018-06-19 |
| Celling Aspiration Needle (K180807) | Spine Smith Holdings, LLC | 2018-05-24 |
| Eviva Stereotactic Guided Breast Biopsy System (K180233) | Hologic, Inc. | 2018-04-10 |
| Corvocet Biopsy System (K180450) | Merit Medical Systems, Inc. | 2018-03-12 |
| Stryker iVAS 13g Bone Biopsy Kit (K180327) | Stryker Corporation | 2018-02-26 |
| Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) (K172344) | Medax Srl Unipersonale | 2017-11-13 |
| iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit (K172558) | Stryker Corporation | 2017-10-05 |
| Bard Mission Disposable Core Biopsy Instrument (K171953) | Bard Peripheral Vascular, Inc. | 2017-09-14 |
| Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle (K171531) | Care Fusion | 2017-09-11 |
| Möller Medical Biopsy Needles and Systems (K162588) | Moller Medical GmbH | 2017-06-19 |
| Brevera Biopsy System with Corlumina Imaging Technology (K163052) | Hologic, Inc. | 2017-03-29 |
| Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm (K170539) | Avitus Orthopaedics, Inc. | 2017-03-20 |
| Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set (K170008) | Cook Incorporated | 2017-02-28 |
| SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles (K160316) | M.D.L. S.R.L. | 2016-10-27 |
| 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 (K153709) | Devicor Medical Products, Inc. | 2016-08-08 |
| CASSI II Rotational Core Biopsy System (K161234) | Scion Medical Technologies, LLC | 2016-08-03 |
| M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem (K161409) | Mermaid Medical A/S | 2016-08-02 |
| EnCor MRI Introducer Set, EnCor Probe Introducer (K161805) | Senorx, Inc. | 2016-07-19 |
| Corvocet Biopsy System (K153337) | Merit Medical Systems, Inc. | 2016-03-25 |
| Mammotome revolve Dual Vacuum Assist Biopsy System (K152989) | Devicor Medical Products, Inc. | 2016-02-25 |
| Intact® Gen2 System (K152596) | Intact Medical Corporation | 2016-02-15 |
| K2M Fenestrated Tap System (K152872) | K2m | 2016-01-05 |
| New Medax Biopsy Systems (K142125) | Medax Srl Unipersonale | 2015-12-22 |
| Imbibe Needle (K153306) | Orthovita, Inc. | 2015-12-18 |
| Avitus Bone Harvester (K152474) | Avitus Orthopaedics, Inc. | 2015-10-23 |
| Sertera Biopsy Device (K150169) | Hologic, Inc. | 2015-08-14 |
| Evacore Fully Disposable Vacuum Assist Biopsy Device (K150088) | Pin-Point Care Corp. | 2015-07-20 |
| Morrison Steerable Needle (K150625) | Apriomed AB | 2015-06-09 |
| Marrow Cellution Bone Marrow Aspiration Needle (K150563) | Ranfac, Corp. | 2015-05-22 |
| Intraosseous Cannula System Bio-MAC¿ and Bio-CORE (K141910) | Biologic Therapies, Inc. | 2015-05-04 |
| Imbibe Aspirating XIA Taps (K143546) | Stryker Corporation | 2015-03-19 |
| Spectra Soft Tissue Biopsy Needles (K142791) | Spectra Medical Devices | 2015-01-21 |
| The OnControl Bone Marrow Biopsy System by Vidacare (K142377) | Vidacare, LLC | 2014-12-17 |
| Intact Advance and Intact Excision XL, Intact BLES (K142477) | Intact Medical Corporation | 2014-12-15 |
| RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE (K140991) | Ranfac, Corp. | 2014-09-11 |
| ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS (K141552) | Care Fusion | 2014-09-05 |
| IVAS 8 GAUGE BONE BIOPSY KIT (K141673) | Stryker Corporation | 2014-09-04 |
| PRESTO BREAST BIOPSY DEVICE (K133702) | Sontina Medical, LLC | 2014-02-28 |
| BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT (K133948) | Bard Peripheral Vascular, Inc. | 2014-02-21 |
| MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES (K130616) | Biopsybell S.R.L. | 2014-02-07 |