| SmartGuide Disposable Guides and Grids (K260161) | UC-CARE , Ltd. | 2026-07-30 |
| ND Needle Guidance System (K262474) | Accurate Access, LLC | 2026-07-27 |
| Accuro® 3S Needle Guide Kit (K261014) | Rivanna Medical, Inc. | 2026-07-24 |
| ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) (K250883) | Olympus Medical Systems Corporation | 2025-09-18 |
| ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) (K250762) | Olympus Medical Systems Corporation | 2025-07-11 |
| Mendaera Guidance System (K250524) | Mendaera, Inc. | 2025-07-02 |
| Accuro® 3S Needle Guide Kit (K250469) | Rivanna Medical, Inc. | 2025-06-13 |
| Ultrasound Transducer Cover (K241662) | Vitrolife Sweden AB | 2024-08-30 |
| UltraDrape UGPIV Barrier and Securement (34-15) (K233965) | Parker Laboratories, Inc. | 2024-08-15 |
| Transducer Probe Cover (K241615) | Hony Medical Co., Ltd. | 2024-07-03 |
| TP Pivot Pro™ Needle Guide (K233109) | Civco Medical Solutions | 2023-12-22 |
| Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (K231666) | FUJIFILM Healthcare Americas Corporation | 2023-12-13 |
| VitroPRO (K231783) | CIVCO Medical Instruments Co., Inc. | 2023-11-14 |
| Disposable Needle Guides and Grids (K223689) | Advance Medical Designs, Inc. | 2023-08-02 |
| Intraoperative Ultrasound Probe Cover (K222460) | Exact Medical Manufacturing | 2023-05-12 |
| Transducer Probe Cover (K221278) | Hony Medical Co., Ltd. | 2023-01-11 |
| VitroPRO (K222052) | CIVCO Medical Instruments Co., Inc. | 2022-11-22 |
| Natural Rubber Latex Ultrasound Transducer Probe Covers (K213087) | Global Protection Corp. | 2022-06-07 |
| CIV-Clear cover (K211270) | CIVCO Medical Instruments Co., Inc. | 2021-09-13 |
| EMM Ultrasonic Transducer Cover (K211969) | Exact Medical Manufacturing | 2021-08-13 |
| Disposable Intraoperative Probe (DIOP8) (K201425) | Huntleigh Healthcare Limited | 2021-02-19 |
| Vscan Air (K202035) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-11-20 |
| EZ-Cover (K191491) | Medxpress.Pro | 2020-06-05 |
| Opticross 35 15 MHz Peripheral Imaging Catheter (K200733) | Boston Scientific Corporation | 2020-04-17 |
| Envision ultrasound pad and cover (K190802) | Civco Medical Solutions | 2019-05-24 |
| Cook-Swartz Doppler Flow Probe (K171272) | Cook Incorporated | 2018-07-17 |
| Disposable guides KDNG00 (K180970) | Koelis | 2018-07-10 |
| Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range (K171040) | Koelis | 2017-07-31 |
| ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor (K163313) | CIVCO Medical Instruments Co., Inc. | 2017-06-09 |
| GTK Disposable Needle Guides (K170741) | Geotek Medikal Ltd Sti | 2017-06-01 |
| Pinpoint GT Needle Guide Kits (K171348) | C.R. Bard, Inc. | 2017-05-22 |
| iSR'obot Biopsy Kit (K163502) | Biobot Surgical Pte., Ltd. | 2017-05-16 |
| A-View (K170338) | Stroke2prevent B.V. | 2017-05-16 |
| UST-5550-R; UST-5536-R; L43K (K152126) | Hitachi Aloka Medical America, Inc. | 2016-08-17 |
| Verza Guidance System (K160806) | CIVCO Medical Instruments Co., Inc. | 2016-08-05 |
| Precision Point Biopsy Needle Guide (K160414) | Corbin Clinical Resources, LLC | 2016-08-01 |
| Sheathes Ultrasound Probe Covers (K153212) | Sheathing Technologies, Inc. | 2016-03-04 |
| Permanent Sled Bag (K152403) | Boston Scientific | 2015-09-22 |
| Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System (K142618) | Hitachi Aloka Medical America, Inc. | 2014-10-16 |
| REUSABLE GUIDE (K141334) | Koelis | 2014-07-11 |
| INTRA-OPERATIVE ULTRASOUND TRANSDUCER (K140854) | Hitachi Aloka Medical, Ltd. | 2014-06-11 |
| 6VT-D ULTRASOUND TRANSDUCER (K141093) | Ge Vingmed Ultrasound AS | 2014-05-15 |
| EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, (K131161) | CIVCO Medical Instruments Co., Inc. | 2013-09-17 |
| NON-PYROGENIC ULTRASOUND TRANSDUCER COVER (K131528) | CIVCO Medical Instruments Co., Inc. | 2013-06-11 |
| MDU5 PLUS STERILE BAG (K123424) | Boston Scientific Corp | 2013-02-20 |
| C1-6-D ULTRASOUND TRANSDUCER (K122921) | GE Healthcare | 2012-10-05 |
| C2-9-D ULTRASOUND TRANSDUCER (K122515) | GE Healthcare | 2012-09-11 |
| VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM (K121062) | Ge Medical System Israel , Ltd. | 2012-08-17 |
| V5MS TRANSDUCER (K121807) | Siemens Medical Solutions USA, Inc. | 2012-07-10 |
| SONICEYE ULTRASOUND TRANSDUCER (K113832) | Blacktoe Medical Iii, Inc. | 2012-03-06 |
| EUCLID (TM) TIER 1-GW ACCESS SYSTEM (K111426) | Houston Medical Robotics | 2012-03-01 |
| PUREIMAGE ULTRASOUND TRANSMISSION GEL (K120156) | Medline | 2012-02-08 |
| HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER (K110752) | Highland Instruments | 2011-06-28 |
| KONIX ULTRASOUND GEL (K101952) | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | 2011-05-27 |
| CUBESCAN / BIOCON-700 (K111021) | Mcube Technology Co., Ltd. | 2011-04-27 |
| DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K110999) | Edan Instruments, Inc. | 2011-04-26 |
| UF-760AG (K110920) | Fukuda Denshi Co., Ltd. | 2011-04-08 |
| FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB (K110202) | Fujifilm Medical System U.S.A., Inc. | 2011-02-08 |
| PET-512MC TRANSESOPHAGEAL TRANSDUCER (K103629) | Toshiba America Medical Systems, In.C | 2011-02-02 |
| TERASON T3200 ULTRASOUND SYSTEM (K110020) | Teratech Corp. | 2011-01-20 |
| APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM (K103645) | Toshiba Medical Systems Corporation, Japan | 2011-01-12 |
| THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM (K103722) | Medison Co., Ltd. | 2011-01-05 |
| DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM (K102865) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-11-03 |
| AIXPLORER (K102041) | Supersonic Imagine | 2010-10-13 |
| STN PROBE (K101816) | Summit Doppler Systems, Inc. | 2010-08-19 |
| SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM (K101757) | Sonosite,Inc. | 2010-08-12 |
| THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM (K101829) | Medison Co., Ltd. | 2010-07-16 |
| DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY (K101008) | Shantou Institute of Ultrasonic Instruments (Siui | 2010-06-08 |
| DC-7 DIAGNOSTIC ULTRASOUND SYSTEM (K101041) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-04-30 |
| SONALIS (K100204) | Smith Associates | 2010-02-19 |
| MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM (K100067) | Toshiba America Medical Systems, In.C | 2010-01-28 |
| ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM (K093713) | Civco Medical Instruments | 2010-01-19 |
| SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM (K093714) | Medison Co., Ltd. | 2009-12-10 |
| SONIX ULTRASOUND SCANNER (K093462) | Ultrasonix Medical Corporation | 2009-11-20 |
| SAFERSONIC SONOGRAPHY COVER (K092858) | Safersonic Medizinprodukte GmbH | 2009-11-10 |
| DC-7 DIAGNOSTIC ULTRASOUND SYSTEM (K092691) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009-10-15 |
| SHEATHESISO ULTRASOUND TRANSDUCER COVER (K091828) | Sheathing Technologies, Inc. | 2009-09-28 |
| GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM (K092756) | Ge Vingmed Ultrasound AS | 2009-09-28 |
| PACSCAN PLUS, MODELS 300P AND 300AP (K092637) | Sonomed, Inc. | 2009-09-24 |
| CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL (K091877) | Chison Medical Imaging Co., Ltd. | 2009-09-02 |
| CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS (K091804) | Philips Ultrasound, Inc. | 2009-07-17 |
| DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM (K091941) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009-07-09 |
| DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K091680) | Edan Instruments, Inc. | 2009-06-19 |
| APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 (K091295) | Toshiba America Medical Systems, In.C | 2009-05-15 |
| DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900 (K090912) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009-04-15 |
| DIGDOP ULTRASOUND SYSTEM (K090465) | The Newman Group, LLC | 2009-04-08 |
| HUMANSCAN M5S-D ULTRASOUND TRANSDUCER (K083824) | Humanscan Company, Ltd. | 2009-02-10 |
| NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 (K083667) | B-K Medical Aps | 2009-02-02 |
| FLYING DIAGNOSTIC ULTRASOUND SYSTEM (K083877) | Neusoft Medical Systems Co., Ltd. | 2009-01-13 |
| DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC (K082224) | Shimadzu Medical Systems | 2008-12-15 |
| PRAGER SHELL (K082893) | Esi, Inc. | 2008-12-05 |
| UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM (K081919) | Fukuda Denshi Co., Ltd. | 2008-09-09 |
| CX50 DIAGNOSTIC ULTRASOUND SYSTEM (K081802) | Philips Ultrasound, Inc. | 2008-07-11 |
| USHIFU STEPPER (K080970) | Ushifu Development Company, LLC | 2008-06-11 |
| SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) (K080555) | Ivu Imaging Corporation | 2008-06-03 |
| ATLANTIS 018 PERIPHERAL IMAGING CATHETER (K073623) | Boston Scientific Corp | 2008-03-13 |
| ATLANTIS PVIMAGING CATHETER, MODEL H749364560 (K080272) | Boston Scientific Corp | 2008-03-11 |
| CLEARSCAN (K080119) | Esi, Inc. | 2008-02-21 |
| ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO (K071289) | Shimadzu Medical Systems | 2008-01-09 |
| ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 (K071291) | Shimadzu Medical Systems | 2008-01-09 |